Bromfenac
- Product NDC
- 65862-789
- 11-digit product format
- 658620789
- Labeler code
- 65862
- Product ID
- 65862-789_56d497cf-0ffc-4f15-8fb6-e66a56f1dfe1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bromfenac
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA204813
- Marketing category
- ANDA
- Marketing start
- 2022-03-18
- 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 |
|---|
| 65862-789-17 | Bromfenac | 1.7 mL in 1 BOTTLE | SOLUTION/ DROPS | 1.7 | | 2 |
| 65862-789-17 | Bromfenac | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-789 | BROMFENAC SOLUTION/ DROPS [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240710_fa40fc6b-1bd0-4496-b53a-8b3e1c122a50.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 |
|---|
| 65862-789-17 | 65862078917 | 1 BOTTLE in 1 CARTON (65862-789-17) / 1.7 mL in 1 BOTTLE | 1 bottle | 2022-03-18 | 0000-00-00 | No | No | Current |