HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Product NDC
- 72189-343
- 11-digit product format
- 721890343
- Labeler code
- 72189
- Product ID
- 72189-343_2eaccf77-5ca1-97e7-e063-6394a90a7c39
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct Rx
- Application
- ANDA211487
- Marketing category
- ANDA
- Marketing start
- 2022-03-30
- 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 BITARTRATE AND ACETAMINOPHEN
- 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 |
|---|
| 72189-343-08 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 8 in 1 BOTTLE | TABLET | 8 | | 11 |
| 72189-343-20 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 20 in 1 BOTTLE | TABLET | 20 | | 11 |
| 72189-343-30 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 30 in 1 BOTTLE | TABLET | 30 | | 11 |
| 72189-343-60 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 60 in 1 BOTTLE | TABLET | 60 | | 11 |
| 72189-343-72 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 120 in 1 BOTTLE | TABLET | 120 | | 11 |
| 72189-343-90 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 90 in 1 BOTTLE | TABLET | 90 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-343 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [DIRECT RX] | 11 | Current NDC, Legacy NDC, 6 package rows | 20250224_db73b8ed-9747-6a49-e053-2a95a90a93a1.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 |
|---|
| 72189-343-08 | 72189034308 | 8 TABLET in 1 BOTTLE (72189-343-08) | 8 tablet | 2022-09-22 | 0000-00-00 | No | No | Current |
| 72189-343-20 | 72189034320 | 20 TABLET in 1 BOTTLE (72189-343-20) | 20 tablet | 2022-03-30 | | No | No | Current |
| 72189-343-30 | 72189034330 | 30 TABLET in 1 BOTTLE (72189-343-30) | 30 tablet | 2022-03-30 | 0000-00-00 | No | No | Current |
| 72189-343-60 | 72189034360 | 60 TABLET in 1 BOTTLE (72189-343-60) | 60 tablet | 2022-03-30 | 0000-00-00 | No | No | Current |
| 72189-343-72 | 72189034372 | 120 TABLET in 1 BOTTLE (72189-343-72) | 120 tablet | 2022-03-30 | 0000-00-00 | No | No | Current |
| 72189-343-90 | 72189034390 | 90 TABLET in 1 BOTTLE (72189-343-90) | 90 tablet | 2022-03-30 | 0000-00-00 | No | No | Current |