Ibuprofen
- Product NDC
- 62135-401
- 11-digit product format
- 621350401
- Labeler code
- 62135
- Product ID
- 62135-401_459c7414-f956-35a9-e063-6294a90aa1d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA202413
- Marketing category
- ANDA
- Marketing start
- 2016-11-23
- Substance
- IBUPROFEN
- Active strength
- 600 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 | 600 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 |
|---|
| 62135-401-12 | Ibuprofen | 120 in 1 PACKAGE | TABLET, FILM COATED | 120 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-401 | IBUPROFEN TABLET, FILM COATED [CHARTWELL RX, LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20241030_39f2664f-6c0a-4726-85d7-4227530d4a49.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 |
|---|
| 62135-401-12 | 62135040112 | 120 TABLET, FILM COATED in 1 PACKAGE (62135-401-12) | 2022-08-10 | 0000-00-00 | No | No | Current |