Ibuprofen
- Product NDC
- 58228-6185
- 11-digit product format
- 582286185
- Labeler code
- 58228
- Product ID
- 58228-6185_3bca27c2-b039-32ae-e063-6294a90a72ee
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PROSTAT FIRST AID
- Application
- ANDA207095
- Marketing category
- ANDA
- Marketing start
- 2025-08-07
- 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 |
|---|
| 58228-6185-1 | Ibuprofen | 2 in 1 PACKET | TABLET | 2 | | 1 |
| 58228-6185-1 | Ibuprofen | 10000 in 1 BAG | TABLET | 10000 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 58228-6185-1 | 58228618501 | 10000 PACKET in 1 BAG (58228-6185-1) / 2 TABLET in 1 PACKET | 10000 packet | 2025-08-07 | No | No | Current |