Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 27808-049
- 11-digit product format
- 278080049
- Labeler code
- 27808
- Product ID
- 27808-049_dc790b2b-c3f6-428c-83f0-0781ded05d6e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Cranbury Pharmaceuticals, LLC
- Application
- ANDA201295
- Marketing category
- ANDA
- Marketing start
- 2021-12-30
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 7.5 mg/15mL; mg/15mL
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrocodone Bitartrate and Acetaminophen
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/15mL |
| HYDROCODONE BITARTRATE | 7.5 mg/15mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
| Rxcui | 856940 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 27808-049-01 | Hydrocodone Bitartrate and Acetaminophen | 473 mL in 1 BOTTLE, PLASTIC | SOLUTION | 473 | | 25 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27808-049 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [TRIS PHARMA INC] | 19 | Current NDC, Legacy NDC, 1 package rows | 20240305_57e1fe79-eb60-4f4f-bb38-6df0270d408f.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 |
|---|
| 27808-049-01 | 27808004901 | 473 mL in 1 BOTTLE, PLASTIC (27808-049-01) | 473 ml | 2022-12-30 | 0000-00-00 | No | No | Current |