Hydrocodone Bitartrate and Homatropine Methylbromide
- Product NDC
- 60687-278
- 11-digit product format
- 606870278
- Labeler code
- 60687
- Product ID
- 60687-278_e23681c5-c7e4-6fcd-e053-2995a90a78fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocodone bitartrate and homatropine methylbromide
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA088008
- Marketing category
- ANDA
- Marketing start
- 2022-06-03
- Marketing end
- 0000-00-00
- Substance
- HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
- Active strength
- 2 mg/5mL; mg/5mL
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60687-278-67 | 60687027867 | 5 TRAY in 1 CASE (60687-278-67) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-278-46) > 5 mL in 1 CUP, UNIT-DOSE (60687-278-40) | 5 tray | 2021-08-01 | 0000-00-00 | No | No | Current |
| 60687-278-86 | 60687027886 | 3 TRAY in 1 CASE (60687-278-86) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-278-46) > 5 mL in 1 CUP, UNIT-DOSE (60687-278-40) | 3 tray | 2021-08-01 | 0000-00-00 | No | No | Current |