Ibuprofen
- Product NDC
- 83059-0019
- 11-digit product format
- 830590019
- Labeler code
- 83059
- Product ID
- 83059-0019_458bacca-6d17-a7fc-e063-6294a90ab9b7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Shield Pharmaceuticals Corp
- Application
- ANDA207095
- Marketing category
- ANDA
- Marketing start
- 2024-01-25
- Substance
- IBUPROFEN
- Active strength
- 200 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 310965 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83059-0019-3 | Ibuprofen | 1 in 1 CARTON | TABLET, COATED | 1 | | 5 |
| 83059-0019-3 | Ibuprofen | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83059-0019 | IBUPROFEN TABLET, COATED [SHIELD PHARMACEUTICALS CORP] | 3 | Current NDC, 2 package rows | 20241228_25f9531b-e674-4c72-af42-ea0ad0a4a706.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83059-0019-3 | 83059001903 | 1 BOTTLE in 1 CARTON (83059-0019-3) / 30 TABLET, COATED in 1 BOTTLE | 1 bottle | 2024-01-25 | No | No | Current |