Bromfenac
- Product NDC
- 60219-1526
- 11-digit product format
- 602191526
- Labeler code
- 60219
- Product ID
- 60219-1526_ba099985-d2c6-4a78-838f-9f2ae98f792a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bromfenac
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA210962
- Marketing category
- ANDA
- Marketing start
- 2024-07-31
- Substance
- BROMFENAC SODIUM
- Active strength
- .7 mg/mL
- 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
- Bromfenac
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BROMFENAC SODIUM | .7 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8ECV571Y37 |
| Rxcui | 1375917 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60219-1526-3 | Bromfenac | 3 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 3 | | 3 |
| 60219-1526-3 | Bromfenac | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60219-1526 | BROMFENAC SOLUTION/ DROPS [AMNEAL PHARMACEUTICALS NY LLC] | 1 | Current NDC, 2 package rows | 20240801_2c4eba0d-db55-4b54-a2ad-dfef1da9462f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 60219-1526-3 | 60219152603 | 1 BOTTLE, DROPPER in 1 CARTON (60219-1526-3) / 3 mL in 1 BOTTLE, DROPPER | 2024-07-31 | No | No | Current |