Ibuprofen
- Product NDC
- 0904-5309
- 11-digit product format
- 009045309
- Labeler code
- 0904
- Product ID
- 0904-5309_d07b6a1b-1390-466f-8cfd-95e809f8044c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA074937
- Marketing category
- ANDA
- Marketing start
- 1999-02-07
- Substance
- IBUPROFEN
- Active strength
- 100 mg/5mL
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197803 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-5309-09 | Ibuprofen | 240 mL in 1 BOTTLE | SUSPENSION | 240 | | 9 |
| 0904-5309-09 | Ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | | 9 |
| 0904-5309-20 | Ibuprofen | 120 mL in 1 BOTTLE | SUSPENSION | 120 | | 9 |
| 0904-5309-20 | Ibuprofen | 1 in 1 CARTON | SUSPENSION | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-5309 | IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS] | 8 | Current NDC, Legacy NDC, 4 package rows | 20250305_847758ed-66fc-4db9-8fdb-78f3c3291a03.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 |
|---|
| 0904-5309-09 | 00904530909 | 1 BOTTLE in 1 CARTON (0904-5309-09) / 240 mL in 1 BOTTLE | 1 bottle | 2003-12-09 | 0000-00-00 | No | No | Current |
| 0904-5309-20 | 00904530920 | 1 BOTTLE in 1 CARTON (0904-5309-20) / 120 mL in 1 BOTTLE | 1 bottle | 1999-02-07 | 0000-00-00 | No | No | Current |