Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 31722-940
- 11-digit product format
- 317220940
- Labeler code
- 31722
- Product ID
- 31722-940_a80ded9e-2f30-4db6-89ac-07af3d13c6b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA211487
- Marketing category
- ANDA
- Marketing start
- 2025-08-22
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 2.5 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 | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NO70W886KK, 362O9ITL9D |
| Rxcui | 857005, 857391 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-940-01 | Hydrocodone Bitartrate and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-940 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [CAMBER PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20210611_4d5bfd3a-3793-4d24-aedd-c04fa34ea736.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 |
|---|
| 31722-940-01 | 31722094001 | 100 TABLET in 1 BOTTLE (31722-940-01) | 100 tablet | 2025-08-22 | 0000-00-00 | No | No | Current |