IBUPROFEN
- Product NDC
- 68071-3362
- 11-digit product format
- 680713362
- Labeler code
- 68071
- Product ID
- 68071-3362_1ce905e8-9477-0b57-e063-6394a90ab525
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IBUPROFEN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA090796
- Marketing category
- ANDA
- Marketing start
- 2015-12-30
- 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
- IBUPROFEN
- 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 |
| Rxcui | 197807 |
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 |
|---|
| 68071-3362-0 | IBUPROFEN | 12 in 1 BOTTLE | TABLET, FILM COATED | 12 | | 6 |
| 68071-3362-1 | IBUPROFEN | 21 in 1 BOTTLE | TABLET, FILM COATED | 21 | | 6 |
| 68071-3362-2 | IBUPROFEN | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 6 |
| 68071-3362-3 | IBUPROFEN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 68071-3362-4 | IBUPROFEN | 40 in 1 BOTTLE | TABLET, FILM COATED | 40 | | 6 |
| 68071-3362-5 | IBUPROFEN | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 6 |
| 68071-3362-6 | IBUPROFEN | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 6 |
| 68071-3362-9 | IBUPROFEN | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3362 | IBUPROFEN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 6 | Current NDC, Legacy NDC, 8 package rows | 20240711_553c8cfa-cf0f-0b1f-e054-00144ff88e88.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 |
|---|
| 68071-3362-0 | 68071336200 | 12 TABLET, FILM COATED in 1 BOTTLE (68071-3362-0) | 2017-07-26 | 0000-00-00 | No | No | Current |
| 68071-3362-1 | 68071336201 | 21 TABLET, FILM COATED in 1 BOTTLE (68071-3362-1) | 2017-07-26 | 0000-00-00 | No | No | Current |
| 68071-3362-2 | 68071336202 | 20 TABLET, FILM COATED in 1 BOTTLE (68071-3362-2) | 2017-07-26 | 0000-00-00 | No | No | Current |
| 68071-3362-3 | 68071336203 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3362-3) | 2017-07-26 | 0000-00-00 | No | No | Current |
| 68071-3362-4 | 68071336204 | 40 TABLET, FILM COATED in 1 BOTTLE (68071-3362-4) | 2017-07-26 | 0000-00-00 | No | No | Current |
| 68071-3362-5 | 68071336205 | 15 TABLET, FILM COATED in 1 BOTTLE (68071-3362-5) | 2017-07-26 | 0000-00-00 | No | No | Current |
| 68071-3362-6 | 68071336206 | 60 TABLET, FILM COATED in 1 BOTTLE (68071-3362-6) | 2017-07-26 | 0000-00-00 | No | No | Current |
| 68071-3362-9 | 68071336209 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-3362-9) | 2017-07-26 | 0000-00-00 | No | No | Current |