Ibuprofen
- Product NDC
- 53329-674
- 11-digit product format
- 533290674
- Labeler code
- 53329
- Product ID
- 53329-674_02818b70-7259-29dc-e063-6294a90a746f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Medline industries, LP
- Application
- ANDA079174
- Marketing category
- ANDA
- Marketing start
- 2017-09-29
- 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 |
|---|
| 53329-674-30 | Ibuprofen | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 53329-674-30 | Ibuprofen | 1 in 1 CARTON | TABLET | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53329-674 | IBUPROFEN TABLET [MEDLINE INDUSTRIES, LP] | 8 | Current NDC, Legacy NDC, 2 package rows | 20230810_5d2482b4-cd90-4246-85a9-fd1d35315b6c.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 |
|---|
| 53329-674-30 | 53329067430 | 1 BOTTLE in 1 CARTON (53329-674-30) / 100 TABLET in 1 BOTTLE | 1 bottle | 2017-09-29 | 0000-00-00 | No | No | Current |