Ibuprofen Oral
- Product NDC
- 50090-4129
- 11-digit product format
- 500904129
- Labeler code
- 50090
- Product ID
- 50090-4129_ab18686c-599d-47b2-863a-1f9c6c0c42f9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen Oral
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA210602
- Marketing category
- ANDA
- Marketing start
- 2018-11-23
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen Oral
- Listing expiration
- 2026-12-31
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 |
|---|
| 50090-4129-0 | Ibuprofen Oral | 1 in 1 CARTON | SUSPENSION | 1 | | 9 |
| 50090-4129-0 | Ibuprofen Oral | 118 mL in 1 BOTTLE | SUSPENSION | 118 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-4129 | IBUPROFEN ORAL SUSPENSION [A-S MEDICATION SOLUTIONS] | 9 | Current NDC, Legacy NDC, 2 package rows | 20231216_a8672e5a-61f2-46d8-9401-432a978d2fd3.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 |
|---|
| 50090-4129-0 | 50090412900 | 1 BOTTLE in 1 CARTON (50090-4129-0) / 118 mL in 1 BOTTLE | 1 bottle | 2019-02-07 | 0000-00-00 | No | No | Current |