NDC 64950-342
Hycodan
Hydrocodone Bitartrate And Homatropine Methylbromide
Hycodan is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Genus Lifesciences Inc.. The primary component is Hydrocodone Bitartrate; Homatropine Methylbromide.
| Product ID | 64950-342_10d1a8d4-a73b-4ffb-864d-435888ad662b |
| NDC | 64950-342 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Hycodan |
| Generic Name | Hydrocodone Bitartrate And Homatropine Methylbromide |
| Dosage Form | Solution |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-06-10 |
| Marketing Category | NDA / NDA |
| Application Number | NDA005213 |
| Labeler Name | Genus Lifesciences Inc. |
| Substance Name | HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE |
| Active Ingredient Strength | 5 mg/5mL; mg/5mL |
| Pharm Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |
| DEA Schedule | CII |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
Packaging
NDC 64950-342-45
40 CUP, UNIT-DOSE in 1 CASE (64950-342-45) > 5 mL in 1 CUP, UNIT-DOSE (64950-342-05)
| Marketing Start Date | 2019-12-16 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 64950-342-47 [64950034247]
Hycodan SOLUTION
| Marketing Category | NDA |
| Application Number | NDA005213 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-06-14 |
NDC 64950-342-05 [64950034205]
Hycodan SOLUTION
| Marketing Category | NDA |
| Application Number | NDA005213 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-12-26 |
NDC 64950-342-45 [64950034245]
Hycodan SOLUTION
| Marketing Category | NDA |
| Application Number | NDA005213 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-12-16 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| HYDROCODONE BITARTRATE | 5 mg/5mL |
OpenFDA Data
| SPL SET ID: | 901d4115-f71a-4681-bd0e-c9b691151b78 |
| Manufacturer | |
| UNII |
Pharmacological Class
- Opioid Agonist [EPC]
- Opioid Agonists [MoA]
NDC Crossover Matching brand name "Hycodan" or generic name "Hydrocodone Bitartrate And Homatropine Methylbromide"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 64950-205 | Hycodan | Hydrocodone Bitartrate and Homatropine Methylbromide |
| 64950-342 | Hycodan | Hydrocodone Bitartrate and Homatropine Methylbromide |
| 0121-4811 | Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone Bitartrate and Homatropine Methylbromide |
| 10702-055 | Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone Bitartrate and Homatropine Methylbromide |
| 13668-577 | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
| 17856-0043 | Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone Bitartrate and Homatropine Methylbromide |
| 17856-0455 | Hydrocodone Bitartrate and Homatropine Methylbromide | hydrocodone bitartrate and homatropine methylbromide |
| 21695-869 | Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone Bitartrate and Homatropine Methylbromide |
| 40032-118 | Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone Bitartrate and Homatropine Methylbromide |
| 40032-810 | Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone Bitartrate and Homatropine Methylbromide |
| 43386-118 | Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone Bitartrate and Homatropine Methylbromide |
| 50383-043 | Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone Bitartrate and Homatropine Methylbromide |
| 59741-262 | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
| 60432-455 | Hydrocodone Bitartrate and Homatropine Methylbromide | hydrocodone bitartrate and homatropine methylbromide |
| 60687-278 | Hydrocodone Bitartrate and Homatropine Methylbromide | hydrocodone bitartrate and homatropine methylbromide |
| 64950-206 | Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone Bitartrate and Homatropine Methylbromide |
| 64950-371 | Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone Bitartrate and Homatropine Methylbromide |
| 66336-871 | Hydrocodone Bitartrate and Homatropine Methylbromide | Hydrocodone Bitartrate and Homatropine Methylbromide |
| 0472-1030 | Hydromet | hydrocodone bitartrate and homatropine methylbromide |
Trademark Results [Hycodan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYCODAN 71455017 0399421 Live/Registered |
Endo Products, Inc. 1942-08-21 |
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