Bromfenac
- Product NDC
- 72485-649
- 11-digit product format
- 724850649
- Labeler code
- 72485
- Product ID
- 72485-649_08a05c09-5f0e-dca3-e063-6294a90a1bc1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bromfenac
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- ARMAS PHARMACEUTICALS INC.
- Application
- ANDA203395
- Marketing category
- ANDA
- Marketing start
- 2023-10-26
- 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
- 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 |
|---|
| 72485-649-71 | Bromfenac | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
| 72485-649-71 | Bromfenac | 1.7 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 1.7 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72485-649 | BROMFENAC SOLUTION/ DROPS [ARMAS PHARMACEUTICALS INC.] | 1 | Current NDC, 2 package rows | 20231101_08a0591e-6cb3-30ce-e063-6394a90a33fb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72485-649-71 | 72485064971 | 1 BOTTLE, DROPPER in 1 CARTON (72485-649-71) / 1.7 mL in 1 BOTTLE, DROPPER | 2023-10-26 | No | No | Current |