BROMFENAC
- Product NDC
- 68180-434
- 11-digit product format
- 681800434
- Labeler code
- 68180
- Product ID
- 68180-434_bde2565a-075e-4910-874b-9737d0ed9ccc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BROMFENAC
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA211239
- Marketing category
- ANDA
- Marketing start
- 2024-02-12
- Substance
- BROMFENAC SODIUM
- Active strength
- .75 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 | .75 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8ECV571Y37 |
| Rxcui | 1790141 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-434-01 | BROMFENAC | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 7 |
| 68180-434-01 | BROMFENAC | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-434 | BROMFENAC SOLUTION/ DROPS [LUPIN PHARMACEUTICALS, INC.] | 6 | Current NDC, 2 package rows | 20250221_2b2621e7-a69e-4286-a7e7-0fc31a91fe29.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68180-434-01 | 68180043401 | 1 BOTTLE in 1 CARTON (68180-434-01) / 5 mL in 1 BOTTLE | 1 bottle | 2024-02-12 | No | No | Current |