Ibuprofen
- Product NDC
- 53746-458
- 11-digit product format
- 537460458
- Labeler code
- 53746
- Product ID
- 53746-458_0a178197-17b9-4e74-a85b-abd0ba469966
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA079233
- Marketing category
- ANDA
- Marketing start
- 2013-04-30
- Substance
- IBUPROFEN
- Active strength
- 200 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 310965 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53746-458-02 | Ibuprofen | 250 in 1 BOTTLE | TABLET | 250 | | 5 |
| 53746-458-10 | Ibuprofen | 1000 in 1 BOTTLE | TABLET | 1000 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-458 | IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240101_59f14d2b-f48a-4c25-bea3-3dc9100898b2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53746-458-02 | 53746045802 | 250 TABLET in 1 BOTTLE (53746-458-02) | 250 tablet | 2013-04-30 | 0000-00-00 | No | No | Current |
| 53746-458-10 | 53746045810 | 1000 TABLET in 1 BOTTLE (53746-458-10) | 1000 tablet | 2013-04-30 | 0000-00-00 | No | No | Current |