Ibuprofen
- Product NDC
- 73614-201
- 11-digit product format
- 736140201
- Labeler code
- 73614
- Product ID
- 73614-201_2dcbe4bb-fb23-e827-e063-6394a90acf9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Brisk Pharmaceuticals
- Application
- ANDA202413
- Marketing category
- ANDA
- Marketing start
- 2024-05-23
- 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
- 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 | 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 |
|---|
| 73614-201-03 | ClindaCare | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 800 mg | 1 |
| 73614-201-03 | Ibuprofen | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 73614-201-03 | Orapaz | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 800 mg | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73614-201 | CLINDACARE (CLINDAMYCIN, IBUPROFEN, CHLORHEXIDINE GLUCONATE) KIT [BRISK PHARMACEUTICALS] | 1 | Current NDC | 20250215_2df8a89c-38df-c63b-e063-6394a90aaa36.zip |
| 73614-201 | IBUPROFEN TABLET, FILM COATED [BRISK PHARMACEUTICALS] | 1 | Current NDC, 1 package rows | 20250213_2dcbe4bb-fb24-e827-e063-6394a90acf9f.zip |
| 73614-201 | ORAPAZ (CEPHALEXIN, IBUPROFEN, CHLORHEXIDINE GLUCONATE) KIT [BRISK PHARMACEUTICALS] | 1 | Current NDC | 20250214_2de0b332-58a3-0bb4-e063-6394a90a1a45.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 73614-201-03 | 73614020103 | 30 TABLET, FILM COATED in 1 BOTTLE (73614-201-03) | 2025-02-10 | No | No | Current |