Hydrocodone APAP
- Product NDC
- 72189-352
- 11-digit product format
- 721890352
- Labeler code
- 72189
- Product ID
- 72189-352_2cc75c9b-0042-6e35-e063-6394a90adfb5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone APAP
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA211487
- Marketing category
- ANDA
- Marketing start
- 2022-05-10
- 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 |
|---|
| 72189-352-30 | Hydrocodone APAP | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 72189-352-60 | Hydrocodone APAP | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
| 72189-352-72 | Hydrocodone APAP | 120 in 1 BOTTLE | TABLET | 120 | | 6 |
| 72189-352-90 | Hydrocodone APAP | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-352 | HYDROCODONE APAP TABLET [DIRECT_RX] | 6 | Current NDC, Legacy NDC, 4 package rows | 20250130_deaa53c1-81ed-7497-e053-2995a90a07cc.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 |
|---|
| 72189-352-30 | 72189035230 | 30 TABLET in 1 BOTTLE (72189-352-30) | 30 tablet | 2022-05-10 | 0000-00-00 | No | No | Current |
| 72189-352-60 | 72189035260 | 60 TABLET in 1 BOTTLE (72189-352-60) | 60 tablet | 2022-05-10 | 0000-00-00 | No | No | Current |
| 72189-352-72 | 72189035272 | 120 TABLET in 1 BOTTLE (72189-352-72) | 120 tablet | 2022-05-10 | | No | No | Current |
| 72189-352-90 | 72189035290 | 90 TABLET in 1 BOTTLE (72189-352-90) | 90 tablet | 2022-05-10 | 0000-00-00 | No | No | Current |