Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 60687-417
- 11-digit product format
- 606870417
- Labeler code
- 60687
- Product ID
- 60687-417_45262987-a079-3a9e-e063-6294a90aa223
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA211023
- Marketing category
- ANDA
- Marketing start
- 2019-06-19
- 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
- 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/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 |
|---|
| 60687-417-44 | Hydrocodone Bitartrate and Acetaminophen | 15 mL in 1 CUP, UNIT-DOSE | SOLUTION | 15 | | 6 |
| 60687-417-50 | Hydrocodone Bitartrate and Acetaminophen | 10 in 1 TRAY | SOLUTION | 10 | | 6 |
| 60687-417-71 | Hydrocodone Bitartrate and Acetaminophen | 5 in 1 CASE | SOLUTION | 5 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-417 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [AMERICAN HEALTH PACKAGING] | 4 | Current NDC, Legacy NDC, 3 package rows | 20240524_f55d0cc9-996e-49c2-b8c1-acaceac99afe.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 |
|---|
| 60687-417-44 | 60687041744 | 15 mL in 1 CUP, UNIT-DOSE | 15 ml | | | | | Historical |
| 60687-417-50 | 60687041750 | 10 in 1 TRAY | | | | | | Historical |
| 60687-417-71 | 60687041771 | 5 TRAY in 1 CASE (60687-417-71) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-417-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-417-44) | 5 tray | 2019-06-19 | 0000-00-00 | No | No | Current |