Hycodan
- Product NDC
- 64950-205
- 11-digit product format
- 649500205
- Labeler code
- 64950
- Product ID
- 64950-205_c1633e0f-dae2-4bd4-ac4d-de8498ee9398
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Homatropine Methylbromide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Genus Lifesciences Inc.
- Application
- NDA005213
- Marketing category
- NDA
- Marketing start
- 2021-11-01
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64950-205 | HYCODAN (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) TABLET HYCODAN (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE) SOLUTION [GENUS LIFESCIENCES INC.] | 7 | Legacy NDC | 20250509_901d4115-f71a-4681-bd0e-c9b691151b78.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64950-205-03 | 64950020503 | 30 TABLET in 1 BOTTLE, PLASTIC (64950-205-03) | 30 tablet | 2021-11-01 | 0000-00-00 | No | No | Current |
| 64950-205-10 | 64950020510 | 100 TABLET in 1 BOTTLE, PLASTIC (64950-205-10) | 100 tablet | 2021-11-01 | 0000-00-00 | No | No | Current |
| 64950-205-30 | 64950020530 | 30 TABLET in 1 BOTTLE, PLASTIC (64950-205-30) | 30 tablet | 2021-11-01 | 0000-00-00 | No | No | Current |