Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 27808-115
- 11-digit product format
- 278080115
- Labeler code
- 27808
- Product ID
- 27808-115_b87bebc7-651b-4b88-8921-cfddb4265559
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cranbury Pharmaceuticals, LLC
- Application
- ANDA202214
- Marketing category
- ANDA
- Marketing start
- 2016-04-07
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 300; 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 Bitartrate and Acetaminophen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 300 mg/1 |
| HYDROCODONE BITARTRATE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NO70W886KK, 362O9ITL9D |
| Rxcui | 856980, 856987, 856992 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 27808-115-01 | Hydrocodone Bitartrate and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | | 30 |
| 27808-115-02 | Hydrocodone Bitartrate and Acetaminophen | 500 in 1 BOTTLE | TABLET | 500 | | 30 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27808-115 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [CRANBURY PHARMACEUTICALS, LLC] | 26 | Current NDC, Legacy NDC, 2 package rows | 20250130_d8fe4ae4-bd19-42eb-b74d-f302b3f914ee.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 |
|---|
| 27808-115-01 | 27808011501 | 100 TABLET in 1 BOTTLE (27808-115-01) | 100 tablet | 2016-04-07 | 0000-00-00 | No | No | Current |
| 27808-115-02 | 27808011502 | 500 TABLET in 1 BOTTLE (27808-115-02) | 500 tablet | 2016-04-07 | 0000-00-00 | No | No | Current |