IBU
- Product NDC
- 10544-625
- 11-digit product format
- 105440625
- Labeler code
- 10544
- Product ID
- 10544-625_0f7b92ea-a829-70a9-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA075682
- Marketing category
- ANDA
- Marketing start
- 2014-01-14
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 400 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 10544-625-40 | IBU | 40 in 1 BOTTLE | TABLET | 40 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | IBU (IBUPROFEN) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | IBU (IBUPROFEN) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | IBU (IBUPROFEN) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | IBU (IBUPROFEN) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | IBU (IBUPROFEN) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | IBU (IBUPROFEN) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IBU (IBUPROFEN) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | IBU (IBUPROFEN) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | IBU (IBUPROFEN) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | IBU (IBUPROFEN) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IBU (IBUPROFEN) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | IBU (IBUPROFEN) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-625 | IBU (IBUPROFEN) TABLET [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 1 package rows | 20150220_0f7b92ea-a828-70a9-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-625-40 | 10544062540 | 40 in 1 BOTTLE | Historical |