Hydrocodone Bitartrate and Ibuprofen
- Product NDC
- 53746-116
- 11-digit product format
- 537460116
- Labeler code
- 53746
- Product ID
- 53746-116_e109d65b-643b-4c2e-80ad-30c7b3e9c160
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA076642
- Marketing category
- ANDA
- Marketing start
- 2010-02-18
- Substance
- HYDROCODONE BITARTRATE; IBUPROFEN
- Active strength
- 2.5; 200 mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], 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 Ibuprofen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCODONE BITARTRATE | 2.5 mg/1 |
| IBUPROFEN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM, NO70W886KK |
| Rxcui | 858770, 858778, 858798, 859315 |
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 |
|---|
| 53746-116-01 | Hydrocodone Bitartrate and Ibuprofen | 100 in 1 BOTTLE | TABLET | 100 | | 46 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROCODONE BITARTRATE | ACTIVE INGREDIENT | NO70W886KK | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 16 | |
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 16 | |
| HYDROCODONE | ACTIVE MOIETY | 6YKS4Y3WQ7 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 16 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 16 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 16 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 16 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 16 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 16 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 16 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 16 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 16 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 16 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 16 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 16 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 16 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 16 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-116 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 42 | Current NDC, Legacy NDC, 1 package rows | 20241030_abc33718-4e88-43ea-9ffa-2b04ffc812ef.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 |
|---|
| 53746-116-01 | 53746011601 | 100 TABLET in 1 BOTTLE (53746-116-01) | 100 tablet | 2010-02-18 | 0000-00-00 | No | No | Current |