Hydrocodone bitartrate
Highest phase reached
Approved
Drug type
Small molecule
First approval year
1943
- First approval year
- 1943
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Hydrocodone bitartrate
- Molecular weight
- 485.49
- Structure (SMILES)
- COc1ccc2c3c1O[C@H]1C(=O)CC[C@H]4[C@@H](C2)N(C)CC[C@]314.O.O.O=C(O)C(O)C(O)C(=O)O
- dicodid
- Dicodid
- hycofenix componenet of hydrocodone bitartrate
- Hycofenix componenet of hydrocodone bitartrate
- hydrocodone bitartrate component of allay
- Hydrocodone bitartrate component of allay
- hydrocodone bitartrate component of anexsia
- Hydrocodone bitartrate component of anexsia
- hydrocodone bitartrate component of azdone
- Hydrocodone bitartrate component of azdone
- hydrocodone bitartrate component of bancap hc
- Hydrocodone bitartrate component of bancap hc
- hydrocodone bitartrate component of co gesic
- Hydrocodone bitartrate component of co-gesic
- hydrocodone bitartrate component of codamine
- Hydrocodone bitartrate component of codamine
- hydrocodone bitartrate component of duradyne dhc
- Hydrocodone bitartrate component of duradyne dhc
- hydrocodone bitartrate component of flowtuss
- Hydrocodone bitartrate component of flowtuss
- hydrocodone bitartrate component of hy phen
- Hydrocodone bitartrate component of hy-phen
- hydrocodone bitartrate component of hycodan
- Hydrocodone bitartrate component of hycodan
- hydrocodone bitartrate component of hycofenix
And 47 more, listed on the interactive page.
- 4 5α epoxy 3 methoxy 17 methylmorphinan 6 one tartrate 1 1 hydrate 2 5
- 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5)
- allay component hydrocodone bitartrate
- ALLAY COMPONENT HYDROCODONE BITARTRATE
- anexsia component hydrocodone bitartrate
- ANEXSIA COMPONENT HYDROCODONE BITARTRATE
- azdone component hydrocodone bitartrate
- AZDONE COMPONENT HYDROCODONE BITARTRATE
- bancap hc component hydrocodone bitartrate
- BANCAP HC COMPONENT HYDROCODONE BITARTRATE
- cep 33237
- CEP-33237
- co gesic component hydrocodone bitartrate
- CO-GESIC COMPONENT HYDROCODONE BITARTRATE
- codamine component hydrocodone bitartrate
- CODAMINE COMPONENT HYDROCODONE BITARTRATE
- dihydrocodeinone bitartrate
- Dihydrocodeinone bitartrate
- dihydrocodeinone bitartrate hydrate
- DIHYDROCODEINONE BITARTRATE HYDRATE
- duradyne dhc component hydrocodone bitartrate
- DURADYNE DHC COMPONENT HYDROCODONE BITARTRATE
- flowtuss component hydrocodone bitartrate
- FLOWTUSS COMPONENT HYDROCODONE BITARTRATE
- humibid and hydrocodone bitartrate tablet
And 75 more, listed on the interactive page.
- CAS registry numbers
- 34195-34-1
- ChEMBL ID
- CHEMBL3989677
- InChIKey
- IUAXSWPNEQYKDR-GXTZACRKSA-N
- RxNorm IDs (RxCUI)
- 142439
- FDA ingredient codes (UNII)
- NO70W886KK
- 23724881
- 134156377
- Applicant
- GENUS
- Approval date
- 23 Mar 1943
- Application number
- NDA005213
- Patents
- 38
- Designations
- 0
- Earliest recorded loss of exclusivity
- 12 Sept 2034
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- United States (FDA)
- Approved
Administration routes
- Oral
- Mechanism
- Opioid receptors; mu/kappa/delta agonist
- Action type
- Agonist
- Target
- Opioid receptors; mu/kappa/delta
- Protein identifier
- P35372
- Mechanism
- Opioid receptors; mu/kappa/delta agonist
- Action type
- Agonist
- Target
- Opioid receptors; mu/kappa/delta
- Protein identifier
- P41143
- Mechanism
- Opioid receptors; mu/kappa/delta agonist
- Action type
- Agonist
- Target
- Opioid receptors; mu/kappa/delta
- Protein identifier
- P41145
Open Targets mechanisms
- Mechanism
- Opioid receptors; mu/kappa/delta agonist
- Action type
- Agonist
- Target
- Opioid receptors; mu/kappa/delta
- Condition
- Wounds and Injuries
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000546
- Subject identifier
- D014947
- Condition
- Liver Diseases
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001421
- Subject identifier
- D008107
- Condition
- Kidney Diseases
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003086
- Subject identifier
- D007674
- Condition
- Pain
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003843
- Subject identifier
- D010146
- Condition
- Acute Pain
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003843
- Subject identifier
- D059787
- Condition
- Substance-Related Disorders
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003890
- Subject identifier
- D019966
- Condition
- Neuralgia
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005762
- Subject identifier
- D009437
- Condition
- Rotator Cuff Injuries
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001250
- Subject identifier
- D000070636
- Condition
- Low Back Pain
- Highest recorded phase
- 3
- Condition identifier
- HP:0003419
- Subject identifier
- D017116
- Condition
- Chronic Pain
- Highest recorded phase
- 3
- Condition identifier
- HP:0012532
- Subject identifier
- D059350
- Condition
- Osteoarthritis
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0005178
- Subject identifier
- D010003
- Condition identifier
- EFO_0001421
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003086
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003890
- Condition identifier
- EFO_0005762
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001250
- Highest recorded phase
- 2
- Condition identifier
- HP_0003419
- Highest recorded phase
- 3
- Condition identifier
- HP_0012531
- Condition identifier
- HP_0012531
- Highest recorded phase
- 4
- Condition identifier
- HP_0012532
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005178
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005178
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005303
- Highest recorded phase
- 4
- Warning
- Black Box Warning
- Warning
- Black Box Warning
- Effect
- misuse
- Warning
- Black Box Warning
- Effect
- respiratory toxicity
- Warning
- Black Box Warning
- Country
- United States
- Warning
- Black Box Warning
- Effect
- misuse
- Country
- United States
- Warning
- Black Box Warning
- Effect
- respiratory toxicity
- Country
- United States
- Event
- agitation
- Reports
- 32
- Reporting signal score
- 31.4708
- Event
- amnesia
- Reports
- 18
- Reporting signal score
- 16.51
- Event
- anxiety
- Reports
- 47
- Reporting signal score
- 31.4309
- Event
- confusional state
- Reports
- 36
- Reporting signal score
- 20.7893
- Event
- constipation
- Reports
- 34
- Reporting signal score
- 15.6611
- Event
- dependence
- Reports
- 39
- Reporting signal score
- 157.731
- Event
- depression
- Reports
- 48
- Reporting signal score
- 33.6834
- Event
- developmental delay
- Reports
- 7
- Reporting signal score
- 16.3904
- Event
- disability
- Reports
- 24
- Reporting signal score
- 72.1253
- Event
- drug abuse
- Reports
- 59
- Reporting signal score
- 101.329
- Event
- drug dependence
- Reports
- 135
- Reporting signal score
- 445.761
- Event
- drug diversion
- Reports
- 6
- Reporting signal score
- 16.81
- Event
- drug hypersensitivity
- Reports
- 115
- Reporting signal score
- 123.571
- Event
- drug tolerance
- Reports
- 8
- Reporting signal score
- 21.1568
- Event
- drug withdrawal syndrome
- Reports
- 55
- Reporting signal score
- 108.089
- Event
- emotional distress
- Reports
- 16
- Reporting signal score
- 26.036
- Event
- feeling abnormal
- Reports
- 36
- Reporting signal score
- 23.6517
- Event
- hallucination
- Reports
- 22
- Reporting signal score
- 17.7246
- Event
- headache
- Reports
- 73
- Reporting signal score
- 19.7801
- Event
- inadequate analgesia
- Reports
- 33
- Reporting signal score
- 119.101
- Event
- insomnia
- Reports
- 45
- Reporting signal score
- 27.5013
- Event
- learning disability
- Reports
- 14
- Reporting signal score
- 68.3766
- Event
- major depression
- Reports
- 11
- Reporting signal score
- 25.1428
- Event
- mental impairment
- Reports
- 13
- Reporting signal score
- 19.1973
- Event
- mental status changes
- Reports
- 20
- Reporting signal score
- 24.5207
And 11 more, listed on the interactive page.
- NCT00236535
- NCT00390260
- NCT00935311
- NCT01758978
- NCT01769677
- NCT02381132
- NCT03121963
- NCT03206749
- NCT03404518
- NCT03584152
- NCT03605914
- NCT04977336
- NCT05034952
- NCT05553366
- NCT05558410
- NCT01081912
- NCT01452529
- NCT01115569
- NCT01319266
- NCT01319279
- NCT01400139
- NCT01596673
- NCT02222740
- NCT03818919
- NCT03818932
- Dose
- 1 to 2 tablets
- How often
- Every 4 to 6 hours as needed for pain
- Do not exceed 8 tablets per day
- Take at the lowest dose necessary to achieve adequate analgesia
- Hydrogen bond acceptors
- 4
- Hydrogen bond donors
- 0
- Polar surface area
- 38.77
- Calculated partition coefficient (ALogP)
- 1.93
- Prodrug
- Yes
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 1
- Heavy atoms
- 34
- Molecular formula
- C22H31NO11
- Monoisotopic mass
- 988.38998629
- Natural product
- No
- 0054-0843
- 0121-1036
- 0121-1544
- 0121-2316
- 0121-4772
- 0245-0410
- 0245-0411
- 0245-0412
- 0406-0123
- 0406-0124
- 0406-0125
- 0406-0376
- 0406-0377
- 0406-0378
- 10702-055
- 10702-150
- 10702-189
- 10702-190
- 10702-191
- 10702-192
- 10702-193
- 10702-194
- 13107-004
- 13107-019
- 13107-020
And 220 more, listed on the interactive page.
- Analgesics, Opioid
- Antitussive Agents
- Narcotics
Related records
Trials (45)
- A Clinical Trial of GRT7040 in Adults With Acute Pain Following Bunionectomy
- A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults
- A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults
- A Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg for Acute Pain and the Prevention of OINV
- A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet
- A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Acute Pain and Opioid-Induced Nausea and Vomiting (OINV)
- A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions
- A Safety, Tolerability and Pharmacokinetic Dose Escalation Study of HC-ER in Patients With Osteoarthritis Pain
- A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy
- A Study of the Efficacy and Safety of Tramadol HCl/Acetaminophen, Hydrocodone Bitartrate/Acetaminophen and Placebo in Patients With Pain From an Ankle Sprain With a Partial Torn Ligament
- A Study to Assess the Abuse Potential of Hydrocodone Extended-Release Tablet in Recreational Opioid Users
- A Study to Assess the Pharmacokinetics of the Hydrocodone Extended-Release Tablet (CEP-33237) in Subjects With Normal Renal Function and Subjects With Varying Degrees of Renal Impairment
- A Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers
- A Study to Evaluate the Pharmacokinetics of the Hydrocodone Extended-Release Tablet (CEP-33237) in Subjects With Normal Hepatic Function and Subjects With Moderate Hepatic Impairment
- Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
- Decreasing Narcotics in Advanced Pelvic Surgery
- Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer
- Effect of Rofecoxib and a Narcotic Analgesic to Treat Pain Following Arthroscopic Surgery (0966-179)(COMPLETED)
- Effect of Ropivacaine During Popliteal Nerve Block in Foot and Ankle Surgery
- Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain
Approved for (1)
- Drug dependence
In development for (6)
- Injury Phase 2
- Kidney disorder Phase 1
- Liver disorder Phase 1
- Neuralgia Phase 3
- Osteoarthritis Phase 2
- Rotator cuff syndrome Phase 2