Ibuprofen
- Product NDC
- 68196-601
- 11-digit product format
- 681960601
- Labeler code
- 68196
- Product ID
- 68196-601_1981f532-be83-7eb6-e063-6394a90aa28d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- SAM'S WEST INC
- Application
- ANDA091239
- Marketing category
- ANDA
- Marketing start
- 2024-06-15
- 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 |
|---|
| 68196-601-60 | Ibuprofen | 600 in 1 BOTTLE | TABLET, COATED | 600 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68196-601 | IBUPROFEN TABLET, COATED [SAM'S WEST INC] | 2 | Current NDC, 1 package rows | 20240616_16595d75-6e74-0839-e063-6394a90abc13.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68196-601-60 | 68196060160 | 600 TABLET, COATED in 1 BOTTLE (68196-601-60) | 2024-06-15 | No | No | Historical |