Hydrocodone/APAP
- Product NDC
- 72189-649
- 11-digit product format
- 721890649
- Labeler code
- 72189
- Product ID
- 72189-649_4a188f02-629f-25cf-e063-6394a90a5766
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone/APAP
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA210211
- Marketing category
- ANDA
- Marketing start
- 2025-11-25
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 5 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrocodone/APAP
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| HYDROCODONE BITARTRATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
| Rxcui | 857002 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-649-20 | Hydrocodone/APAP | 20 in 1 BOTTLE | TABLET | 20 | | 3 |
| 72189-649-30 | Hydrocodone/APAP | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 72189-649-60 | Hydrocodone/APAP | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-649-20 | 72189064920 | 20 TABLET in 1 BOTTLE (72189-649-20) | 20 tablet | 2025-11-25 | No | No | Historical |
| 72189-649-30 | 72189064930 | 30 TABLET in 1 BOTTLE (72189-649-30) | 30 tablet | 2025-11-25 | No | No | Historical |
| 72189-649-60 | 72189064960 | 60 TABLET in 1 BOTTLE (72189-649-60) | 60 tablet | 2025-11-25 | No | No | Historical |