Ibuprofen
- Product NDC
- 53746-142
- 11-digit product format
- 537460142
- Labeler code
- 53746
- Product ID
- 53746-142_ef67c08a-fc4f-4e6c-a58f-8ed743b2b6aa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA072199
- Marketing category
- ANDA
- Marketing start
- 2009-12-16
- 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
- Brand name suffix
- (NSAID) Pain Releiver/ Fever Reducer
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53746-142-01 | Ibuprofen(NSAID) Pain Releiver/ Fever Reducer | 100 in 1 BOTTLE | TABLET | 100 | | 11 |
| 53746-142-10 | Ibuprofen(NSAID) Pain Releiver/ Fever Reducer | 1000 in 1 BOTTLE | TABLET | 1000 | | 11 |
| 53746-142-24 | Ibuprofen(NSAID) Pain Releiver/ Fever Reducer | 24 in 1 BOTTLE | TABLET | 24 | | 11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-142 | IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 11 | Current NDC, Legacy NDC, 3 package rows | 20240101_a8c6bc4e-1e48-4613-8cbf-8c5cd9d51ad0.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 |
|---|
| 53746-142-01 | 53746014201 | 100 TABLET in 1 BOTTLE (53746-142-01) | 100 tablet | 2009-12-16 | 0000-00-00 | No | No | Current |
| 53746-142-10 | 53746014210 | 1000 TABLET in 1 BOTTLE (53746-142-10) | 1000 tablet | 2009-12-16 | 0000-00-00 | No | No | Current |
| 53746-142-24 | 53746014224 | 24 TABLET in 1 BOTTLE (53746-142-24) | 24 tablet | 2009-12-16 | 0000-00-00 | No | No | Current |