Hydrocodone/APAP
- Product NDC
- 72189-407
- 11-digit product format
- 721890407
- Labeler code
- 72189
- Product ID
- 72189-407_2c4cf13b-5454-0aa9-e063-6394a90ac235
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone/APAP
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA040409
- Marketing category
- ANDA
- Marketing start
- 2022-12-28
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrocodone/APAP
- Listing expiration
- 2026-12-31
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 |
|---|
| 72189-407-30 | Hydrocodone/APAP | 30 in 1 BOTTLE | TABLET | 30 | | 8 |
| 72189-407-60 | Hydrocodone/APAP | 60 in 1 BOTTLE | TABLET | 60 | | 8 |
| 72189-407-72 | Hydrocodone/APAP | 120 in 1 BOTTLE | TABLET | 120 | | 8 |
| 72189-407-90 | Hydrocodone/APAP | 90 in 1 BOTTLE | TABLET | 90 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-407 | HYDROCODONE/APAP TABLET [DIRECT_RX] | 8 | Current NDC, Legacy NDC, 4 package rows | 20250123_f0e66441-668a-7ab8-e053-2995a90aba4f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72189-407-30 | 72189040730 | 30 TABLET in 1 BOTTLE (72189-407-30) | 30 tablet | 2022-12-28 | | No | No | Current |
| 72189-407-60 | 72189040760 | 60 TABLET in 1 BOTTLE (72189-407-60) | 60 tablet | 2022-12-28 | 0000-00-00 | No | No | Current |
| 72189-407-72 | 72189040772 | 120 TABLET in 1 BOTTLE (72189-407-72) | 120 tablet | 2022-12-28 | | No | No | Current |
| 72189-407-90 | 72189040790 | 90 TABLET in 1 BOTTLE (72189-407-90) | 90 tablet | 2022-12-28 | 0000-00-00 | No | No | Current |