Ibuprofen
- Product NDC
- 68210-4192
- 11-digit product format
- 682104192
- Labeler code
- 68210
- Product ID
- 68210-4192_292de647-d3cc-29a1-e063-6394a90a4fd0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Spirit Pharmaceuticals LLC
- Application
- ANDA079174
- Marketing category
- ANDA
- Marketing start
- 2021-12-08
- 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 |
|---|
| 68210-4192-2 | Ibuprofen | 25 in 1 BOTTLE | TABLET, FILM COATED | 25 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68210-4192 | IBUPROFEN TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20241215_e38d23e5-b455-41b5-86f6-c318b17bd345.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 |
|---|
| 68210-4192-2 | 68210419202 | 25 TABLET, FILM COATED in 1 BOTTLE (68210-4192-2) | 2021-12-08 | 0000-00-00 | No | No | Current |