Hydrocodone Bitartrate and Homatropine Methylbromide
- Product NDC
- 0121-4811
- 11-digit product format
- 001214811
- Labeler code
- 0121
- Product ID
- 0121-4811_d2bc7ada-7c23-34be-e053-2a95a90ac145
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Homatropine Methylbromide
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Pharmaceutical Associates, Inc.
- Application
- ANDA088008
- Marketing category
- ANDA
- Marketing start
- 2009-12-28
- 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
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0121-4811-40 | 00121481140 | 4 TRAY in 1 CASE (0121-4811-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-4811-05) | 4 tray | 2009-12-28 | 0000-00-00 | No | No | Current |