Hycodan
- Product NDC
- 64950-342
- 11-digit product format
- 649500342
- Labeler code
- 64950
- Product ID
- 64950-342_c1633e0f-dae2-4bd4-ac4d-de8498ee9398
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Homatropine Methylbromide
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Genus Lifesciences Inc.
- Application
- NDA005213
- Marketing category
- NDA
- Marketing start
- 2019-06-10
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE
- Active strength
- 5 mg/5mL; mg/5mL
- 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 |
|---|
| 64950-342 | 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 |
|---|
| 64950-342-45 | 64950034245 | 40 CUP, UNIT-DOSE in 1 CASE (64950-342-45) > 5 mL in 1 CUP, UNIT-DOSE (64950-342-05) | | 2019-12-16 | 0000-00-00 | No | No | Current |
| 64950-342-47 | 64950034247 | 473 mL in 1 BOTTLE (64950-342-47) | 473 ml | 2019-06-14 | 0000-00-00 | No | No | Current |