Ibuprofen
- Product NDC
- 51655-354
- 11-digit product format
- 516550354
- Labeler code
- 51655
- Product ID
- 51655-354_48eb6abe-de2a-0a22-e063-6294a90a49a7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA075010
- Marketing category
- ANDA
- Marketing start
- 2020-05-27
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen
- Listing expiration
- 2027-12-31
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 |
|---|
| 51655-354-26 | Ibuprofen | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-354 | IBUPROFEN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20231221_ab313564-27dc-0297-e053-2a95a90a6690.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 |
|---|
| 51655-354-26 | 51655035426 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-354-26) | 2020-05-27 | 0000-00-00 | No | No | Current |