HYDROCODONE/APAP
- Product NDC
- 72189-406
- 11-digit product format
- 721890406
- Labeler code
- 72189
- Product ID
- 72189-406_2c4cdc9e-f775-a44a-e063-6294a90a3c96
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCODONE/APAP
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA040405
- Marketing category
- ANDA
- Marketing start
- 2022-12-15
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 7.5 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 | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
| Rxcui | 857005 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-406-30 | HYDROCODONE/APAP | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
| 72189-406-60 | HYDROCODONE/APAP | 60 in 1 BOTTLE | TABLET | 60 | | 7 |
| 72189-406-90 | HYDROCODONE/APAP | 90 in 1 BOTTLE | TABLET | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-406 | HYDROCODONE/APAP TABLET [DIRECT_RX] | 7 | Current NDC, Legacy NDC, 3 package rows | 20250123_efe3b2eb-5c26-3783-e053-2995a90a6ba8.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 |
|---|
| 72189-406-30 | 72189040630 | 30 TABLET in 1 BOTTLE (72189-406-30) | 30 tablet | 2022-12-15 | | No | No | Historical |
| 72189-406-60 | 72189040660 | 60 TABLET in 1 BOTTLE (72189-406-60) | 60 tablet | 2022-12-15 | | No | No | Historical |
| 72189-406-90 | 72189040690 | 90 TABLET in 1 BOTTLE (72189-406-90) | 90 tablet | 2022-12-15 | 0000-00-00 | No | No | Current |