Ibuprofen
- Product NDC
- 69150-800
- 11-digit product format
- 691500800
- Labeler code
- 69150
- Product ID
- 69150-800_8a81f004-63e2-4cc7-b779-43a75bc26673
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IBUPROFEN
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Biomes Pharmaceuticals LLC
- Application
- ANDA078329
- Marketing category
- ANDA
- Marketing start
- 2009-05-02
- Marketing end
- 0000-00-00
- Substance
- IBUPROFEN
- Active strength
- 800 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 |
|---|
| 69150-800-10 | Ibuprofen | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 2 |
| 69150-800-50 | Ibuprofen | 500 in 1 BOTTLE | TABLET, COATED | 500 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC] | 2 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC] | 2 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69150-800 | IBUPROFEN TABLET, COATED [BIOMES PHARMACEUTICALS LLC] | 2 | Legacy NDC, 2 package rows | 20141114_e87089e0-46c4-4fa4-b16e-d74eb7834fe2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 69150-800-10 | 69150080010 | 100 in 1 BOTTLE | Historical |
| 69150-800-50 | 69150080050 | 500 in 1 BOTTLE | Historical |