Ibuprofen
- Product NDC
- 51655-042
- 11-digit product format
- 516550042
- Labeler code
- 51655
- Product ID
- 51655-042_46ddb744-4ce4-38d1-e063-6294a90acb43
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA091625
- Marketing category
- ANDA
- Marketing start
- 2022-09-09
- Substance
- IBUPROFEN
- Active strength
- 600 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 | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197806 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-042-20 | Ibuprofen | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | | 3 |
| 51655-042-25 | Ibuprofen | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 3 |
| 51655-042-26 | Ibuprofen | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 3 |
| 51655-042-52 | Ibuprofen | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-042 | IBUPROFEN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 2 | Current NDC, 4 package rows | 20230706_f2a08223-a73a-5461-e053-2995a90a3bce.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-042-20 | 51655004220 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-042-20) | 2023-01-08 | No | No | Current |
| 51655-042-25 | 51655004225 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-042-25) | 2022-09-09 | No | No | Current |
| 51655-042-26 | 51655004226 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-042-26) | 2022-12-14 | No | No | Current |
| 51655-042-52 | 51655004252 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-042-52) | 2023-06-28 | No | No | Current |