Ibuprofen
- Product NDC
- 82868-069
- 11-digit product format
- 828680069
- Labeler code
- 82868
- Product ID
- 82868-069_476c1a73-f116-0891-e063-6394a90a87cd
- 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
- 2024-11-20
- 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
- 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 | 800 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197807 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82868-069-30 | Ibuprofen | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 4 |
| 82868-069-60 | Ibuprofen | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 4 |
| 82868-069-90 | 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 |
|---|
| 82868-069 | IBUPROFEN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 2 | Current NDC, 3 package rows | 20250228_2f12a20c-4293-d18a-e063-6294a90a3afc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82868-069-30 | 82868006930 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-069-30) | 2024-11-20 | No | No | Historical |
| 82868-069-60 | 82868006960 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-069-60) | 2025-06-27 | No | No | Historical |
| 82868-069-90 | 82868006990 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-069-90) | 2024-11-20 | No | No | Historical |