Ibuprofen
- Product NDC
- 85509-2396
- 11-digit product format
- 855092396
- Labeler code
- 85509
- Product ID
- 85509-2396_3b51bdea-0879-d416-e063-6394a90a84b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PHOENIX RX LLC
- Application
- ANDA202413
- Marketing category
- ANDA
- Marketing start
- 2024-05-23
- Substance
- IBUPROFEN
- Active strength
- 800 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 | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197807 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85509-2396-3 | Ibuprofen | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 85509-2396-6 | Ibuprofen | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 85509-2396-9 | Ibuprofen | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 85509-2396-3 | 85509239603 | 30 TABLET, FILM COATED in 1 BOTTLE (85509-2396-3) | 2025-07-30 | No | No | Historical |
| 85509-2396-6 | 85509239606 | 60 TABLET, FILM COATED in 1 BOTTLE (85509-2396-6) | 2025-07-30 | No | No | Historical |
| 85509-2396-9 | 85509239609 | 90 TABLET, FILM COATED in 1 BOTTLE (85509-2396-9) | 2025-07-30 | No | No | Historical |