Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 0121-2316
- 11-digit product format
- 001212316
- Labeler code
- 0121
- Product ID
- 0121-2316_1c5f2752-d5b9-4830-bc53-31c816f2bc09
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCODONE BITARTRATE and ACETAMINOPHEN
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA040838
- Marketing category
- ANDA
- Marketing start
- 2013-07-29
- 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 |
|---|
| 0121-2316-15 | Hydrocodone Bitartrate and Acetaminophen | 15 mL in 1 CUP, UNIT-DOSE | SOLUTION | 15 | | 25 |
| 0121-2316-40 | Hydrocodone Bitartrate and Acetaminophen | 10 in 1 TRAY | SOLUTION | 10 | | 25 |
| 0121-2316-40 | Hydrocodone Bitartrate and Acetaminophen | 4 in 1 CASE | SOLUTION | 4 | | 25 |
| 0121-2316-50 | Hydrocodone Bitartrate and Acetaminophen | 10 in 1 TRAY | SOLUTION | 10 | | 25 |
| 0121-2316-50 | Hydrocodone Bitartrate and Acetaminophen | 5 in 1 CASE | SOLUTION | 5 | | 25 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 4 | |
| HYDROCODONE BITARTRATE | ACTIVE INGREDIENT | NO70W886KK | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 4 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 4 | |
| HYDROCODONE | ACTIVE MOIETY | 6YKS4Y3WQ7 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 4 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 4 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 4 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 4 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 4 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 4 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 4 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 4 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 4 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-2316 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 24 | Current NDC, Legacy NDC, 5 package rows | 20250306_c29b97e9-8097-4d87-a420-ccf5aec8274a.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 |
|---|
| 0121-2316-15 | 00121231615 | 15 mL in 1 CUP, UNIT-DOSE | 15 ml | | | | | Historical |
| 0121-2316-40 | 00121231640 | 4 TRAY in 1 CASE (0121-2316-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE (0121-2316-15) | 4 tray | 2013-07-29 | 0000-00-00 | No | No | Current |
| 0121-2316-50 | 00121231650 | 5 TRAY in 1 CASE (0121-2316-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE | 5 tray | 2020-05-21 | 0000-00-00 | No | No | Current |