Ibuprofen
- Product NDC
- 50090-5819
- 11-digit product format
- 500905819
- Labeler code
- 50090
- Product ID
- 50090-5819_928aea26-2b55-4e1c-9a7d-9aeddfdb32a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA078329
- Marketing category
- ANDA
- Marketing start
- 2018-08-24
- Substance
- IBUPROFEN
- Active strength
- 400 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 | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197805 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-5819-0 | Ibuprofen | 16 in 1 BOTTLE | TABLET, FILM COATED | 16 | | 6 |
| 50090-5819-1 | Ibuprofen | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 50090-5819-3 | Ibuprofen | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 6 |
| 50090-5819-4 | Ibuprofen | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 6 |
| 50090-5819-8 | Ibuprofen | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-5819 | IBUPROFEN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 6 | Current NDC, Legacy NDC, 5 package rows | 20231125_400faee1-f662-470e-bcd6-7711dfaf9ba2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-5819-0 | 50090581900 | 16 TABLET, FILM COATED in 1 BOTTLE (50090-5819-0) | 2021-10-19 | 0000-00-00 | No | No | Current |
| 50090-5819-1 | 50090581901 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-5819-1) | 2021-10-19 | 0000-00-00 | No | No | Current |
| 50090-5819-3 | 50090581903 | 100 TABLET, FILM COATED in 1 BOTTLE (50090-5819-3) | 2021-10-19 | 0000-00-00 | No | No | Current |
| 50090-5819-4 | 50090581904 | 20 TABLET, FILM COATED in 1 BOTTLE (50090-5819-4) | 2021-10-19 | 0000-00-00 | No | No | Current |
| 50090-5819-8 | 50090581908 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-5819-8) | 2021-10-19 | 0000-00-00 | No | No | Current |