Ibuprofen
- Product NDC
- 12634-518
- 11-digit product format
- 126340518
- Labeler code
- 12634
- Product ID
- 12634-518_2757f53a-602c-4678-80f5-61c3d9dfd4a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotheca, Inc
- Application
- ANDA091239
- Marketing category
- ANDA
- Marketing start
- 2014-02-14
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 200 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- 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 |
|---|
| 12634-518-01 | Ibuprofen | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 12634-518-10 | Ibuprofen | 1000 in 1 BOTTLE | TABLET | 1000 | | 1 |
| 12634-518-74 | Ibuprofen | 24 in 1 BOTTLE | TABLET | 24 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC] | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 12634-518 | IBUPROFEN (IBUPROFEN) TABLET [APOTHECA, INC] | 1 | Legacy NDC, 3 package rows | 20140405_3fd625e4-0d06-4efb-abd1-42281e7a6af0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 12634-518-01 | 12634051801 | 100 in 1 BOTTLE | Historical |
| 12634-518-10 | 12634051810 | 1000 in 1 BOTTLE | Historical |
| 12634-518-74 | 12634051874 | 24 in 1 BOTTLE | Historical |