Bromfenac
- Product NDC
- 68180-436
- 11-digit product format
- 681800436
- Labeler code
- 68180
- Product ID
- 68180-436_8df89f04-52dd-4d9c-8cf3-9c045e669463
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bromfenac
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA202903
- Marketing category
- ANDA
- Marketing start
- 2024-02-02
- Substance
- BROMFENAC SODIUM
- Active strength
- .9 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 | .9 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8ECV571Y37 |
| Rxcui | 578018 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-436-01 | Bromfenac | 1.7 mL in 1 BOTTLE | SOLUTION | 1.7 | | 5 |
| 68180-436-01 | Bromfenac | 1 in 1 CARTON | SOLUTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-436 | BROMFENAC SOLUTION [LUPIN PHARMACEUTICALS, INC.] | 4 | Current NDC, 2 package rows | 20250119_2fc689b7-d5ba-4591-8c23-b48e588d7a28.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 |
|---|
| 68180-436-01 | 68180043601 | 1 BOTTLE in 1 CARTON (68180-436-01) / 1.7 mL in 1 BOTTLE | 1 bottle | 2024-02-02 | No | No | Historical |