Ibuprofen
- Product NDC
- 0904-5577
- 11-digit product format
- 009045577
- Labeler code
- 0904
- Product ID
- 0904-5577_f35a9991-30e5-4391-b327-b5c2bf7fa809
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA074937
- Marketing category
- ANDA
- Marketing start
- 2002-04-03
- 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
- Brand name suffix
- Childrens
- 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 |
|---|
| 0904-5577-20 | IbuprofenChildrens | 120 mL in 1 BOTTLE | SUSPENSION | 120 | | 7 |
| 0904-5577-20 | IbuprofenChildrens | 1 in 1 CARTON | SUSPENSION | 1 | | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-5577 | IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [MAJOR PHARMACEUTICALS] | 5 | Current NDC, Legacy NDC, 2 package rows | 20180216_9d56e64d-7860-4fd1-88d2-c537e50079d8.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 |
|---|
| 0904-5577-20 | 00904557720 | 1 BOTTLE in 1 CARTON (0904-5577-20) / 120 mL in 1 BOTTLE | 1 bottle | 2002-04-03 | 0000-00-00 | No | No | Current |