Bromfenac Ophthalmic Solution 0.09%
- Product NDC
- 62332-508
- 11-digit product format
- 623320508
- Labeler code
- 62332
- Product ID
- 62332-508_824d37d0-e25f-4df8-be0e-d9a65046fc10
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bromfenac Ophthalmic Solution 0.09%
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA210560
- Marketing category
- ANDA
- Marketing start
- 2019-06-21
- Substance
- BROMFENAC SODIUM
- Active strength
- 1.035 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 Ophthalmic Solution 0.09%
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BROMFENAC SODIUM | 1.035 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 |
|---|
| 62332-508-17 | Bromfenac Ophthalmic Solution 0.09% | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 7 |
| 62332-508-17 | Bromfenac Ophthalmic Solution 0.09% | 1.7 mL in 1 BOTTLE | SOLUTION/ DROPS | 1.7 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-508 | BROMFENAC OPHTHALMIC SOLUTION 0.09% SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250207_225070ee-d862-4d41-84b8-5bd7a8a03fd7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62332-508-17 | 62332050817 | 1 BOTTLE in 1 CARTON (62332-508-17) / 1.7 mL in 1 BOTTLE | 1 bottle | 2019-06-21 | 0000-00-00 | No | No | Current |