Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 0121-0772
- 11-digit product format
- 001210772
- Labeler code
- 0121
- Product ID
- 0121-0772_e17e391f-c75d-1bdc-e053-2a95a90a9401
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCODONE BITARTRATE and ACETAMINOPHEN
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Pharmaceutical Associates, Inc.
- Application
- ANDA040838
- Marketing category
- ANDA
- Marketing start
- 2013-07-29
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325 mg/15mL; mg/15mL
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
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 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 |
|---|
| 0121-0772-04 | 00121077204 | 118 mL in 1 BOTTLE (0121-0772-04) | 118 ml | 2013-07-29 | 0000-00-00 | No | No | Current |
| 0121-0772-16 | 00121077216 | 473 mL in 1 BOTTLE (0121-0772-16) | 473 ml | 2013-07-29 | 0000-00-00 | No | No | Current |