Ibuprofen
- Product NDC
- 69238-1101
- 11-digit product format
- 692381101
- Labeler code
- 69238
- Product ID
- 69238-1101_9fdca868-ff3e-4871-9921-9ef7adc577e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA078329
- Marketing category
- ANDA
- Marketing start
- 2014-04-01
- Substance
- IBUPROFEN
- Active strength
- 400 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197805, 197806, 197807 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69238-1101-5 | Ibuprofen | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | IBUPROFEN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | IBUPROFEN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | IBUPROFEN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | IBUPROFEN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | IBUPROFEN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | IBUPROFEN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | IBUPROFEN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | IBUPROFEN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | IBUPROFEN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | IBUPROFEN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | IBUPROFEN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | IBUPROFEN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1101 | IBUPROFEN TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20231231_e07d989d-1b0e-4cc1-abf2-93c8b208a29a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69238-1101-5 | 69238110105 | 500 TABLET, FILM COATED in 1 BOTTLE (69238-1101-5) | 2014-04-01 | 0000-00-00 | No | No | Current |