Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 12634-616
- 11-digit product format
- 126340616
- Labeler code
- 12634
- Product ID
- 12634-616_91924151-259e-4f6b-869c-01ba4a4729ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocodone bitartrate and acetaminophen
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Apotheca, Inc
- Application
- ANDA040838
- Marketing category
- ANDA
- Marketing start
- 2014-03-31
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 8 mg/120mL; mg/120mL
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 12634-616-04 | Hydrocodone Bitartrate and Acetaminophen | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC] | 2 | |
| HYDROCODONE BITARTRATE | ACTIVE INGREDIENT | NO70W886KK | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC] | 2 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC] | 2 | |
| HYDROCODONE | ACTIVE MOIETY | 6YKS4Y3WQ7 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC] | 2 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC] | 2 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC] | 2 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC] | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC] | 2 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC] | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC] | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 12634-616 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [APOTHECA, INC] | 2 | Legacy NDC, 1 package rows | 20141024_fe6e60c8-53de-4b77-825d-b7427a63f54c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 12634-616-04 | 12634061604 | 120 mL in 1 BOTTLE | 120 ml | Historical |