HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Product NDC
- 0054-0843
- 11-digit product format
- 000540843
- Labeler code
- 0054
- Product ID
- 0054-0843_250056d2-c06c-76f1-e063-6394a90aec19
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA040881
- Marketing category
- ANDA
- Marketing start
- 2025-06-02
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 300; 10 mg/15mL; mg/15mL
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 300 mg/15mL |
| HYDROCODONE BITARTRATE | 10 mg/15mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0843-63 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 473 mL in 1 BOTTLE | LIQUID | 473 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0054-0843-63 | 00054084363 | 473 mL in 1 BOTTLE (0054-0843-63) | 473 ml | 2025-06-16 | No | No | Historical |