Ibuprofen
- Product NDC
- 52605-117
- 11-digit product format
- 526050117
- Labeler code
- 52605
- Product ID
- 52605-117_c265106e-3575-4073-8195-0aa0adb10f45
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Polygen Pharmaceuticals LLC
- Application
- ANDA091239
- Marketing category
- ANDA
- Marketing start
- 2012-06-05
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 200 mg/1
- 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 |
|---|
| 52605-117-01 | Ibuprofen | 1 in 1 CARTON | TABLET, COATED | 1 | | 6 |
| 52605-117-01 | Ibuprofen | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] | 6 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] | 6 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] | 6 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] | 6 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] | 6 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] | 6 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] | 6 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52605-117 | IBUPROFEN (IBUPROFEN ) TABLET, COATED IBUPROFEN TABLET, COATED [POLYGEN PHARMACEUTICALS LLC] | 6 | Legacy NDC, 2 package rows | 20130627_00bc1e01-f90e-444d-b7d6-807797a1d136.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 52605-117-01 | 52605011701 | 1 in 1 CARTON | Historical |