IBU
- Product NDC
- 71610-275
- 11-digit product format
- 716100275
- Labeler code
- 71610
- Product ID
- 71610-275_8205e32a-d524-488b-b591-bc4d697896c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA075682
- Marketing category
- ANDA
- Marketing start
- 2008-11-20
- Substance
- IBUPROFEN
- Active strength
- 800 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
- IBU
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-275-60 | IBU | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
| 71610-275-80 | IBU | 180 in 1 BOTTLE | TABLET | 180 | | 1 |
| 71610-275-92 | IBU | 270 in 1 BOTTLE | TABLET | 270 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-275 | IBU (IBUPROFEN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 3 package rows | 20190516_ffec2f44-1144-4729-b43a-1db40ea6a8d3.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71610-275-60 | 71610027560 | 90 TABLET in 1 BOTTLE (71610-275-60) | 90 tablet | 2019-05-08 | 0000-00-00 | No | No | Current |
| 71610-275-80 | 71610027580 | 180 TABLET in 1 BOTTLE (71610-275-80) | 180 tablet | 2019-05-08 | 0000-00-00 | No | No | Current |
| 71610-275-92 | 71610027592 | 270 TABLET in 1 BOTTLE (71610-275-92) | 270 tablet | 2019-05-08 | 0000-00-00 | No | No | Current |