HYDROCODONE BITARTRATE AND IBUPROFEN
- Product NDC
- 33261-378
- 11-digit product format
- 332610378
- Labeler code
- 33261
- Product ID
- 33261-378_8e28c38a-8d9f-489f-82f9-d13d7d7a4c97
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCODONE BITARTRATE AND IBUPROFEN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA076604
- Marketing category
- ANDA
- Marketing start
- 2008-08-27
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; IBUPROFEN
- Active strength
- 8 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- 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 |
|---|
| 33261-378-00 | HYDROCODONE BITARTRATE AND IBUPROFEN | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 3 |
| 33261-378-02 | HYDROCODONE BITARTRATE AND IBUPROFEN | 120 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 120 | | 3 |
| 33261-378-10 | HYDROCODONE BITARTRATE AND IBUPROFEN | 10 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 10 | | 3 |
| 33261-378-30 | HYDROCODONE BITARTRATE AND IBUPROFEN | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 3 |
| 33261-378-60 | HYDROCODONE BITARTRATE AND IBUPROFEN | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 3 |
| 33261-378-90 | HYDROCODONE BITARTRATE AND IBUPROFEN | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 3 |
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, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 2 | |
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 2 | |
| HYDROCODONE | ACTIVE MOIETY | 6YKS4Y3WQ7 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 2 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 2 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 2 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 2 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 2 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 2 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 2 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33261-378 | HYDROCODONE BITARTRATE AND IBUPROFEN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 3 | Legacy NDC, 6 package rows | 20180523_80140ebb-0d9c-4cab-bb8b-951849291b13.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 33261-378-00 | 33261037800 | 100 in 1 BOTTLE, PLASTIC | Historical |
| 33261-378-02 | 33261037802 | 120 in 1 BOTTLE, PLASTIC | Historical |
| 33261-378-10 | 33261037810 | 10 in 1 BOTTLE, PLASTIC | Historical |
| 33261-378-30 | 33261037830 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 33261-378-60 | 33261037860 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 33261-378-90 | 33261037890 | 90 in 1 BOTTLE, PLASTIC | Historical |