BROMSITE
- Product NDC
- 49708-754
- 11-digit product format
- 497080754
- Labeler code
- 49708
- Product ID
- 49708-754_47daa628-c56f-1e9d-e063-6294a90a3d33
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bromfenac
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- NDA206911
- Marketing category
- NDA
- Marketing start
- 2016-05-01
- Substance
- BROMFENAC SODIUM
- Active strength
- .76 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BROMSITE
- Brand name suffix
- 0.075%
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BROMFENAC SODIUM | .76 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8ECV571Y37 |
| Rxcui | 1790141, 1790146 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49708-754-41 | BROMSITE0.075% | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 5 |
| 49708-754-41 | BROMSITE0.075% | 1 in 1 POUCH | SOLUTION/ DROPS | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49708-754 | BROMSITE 0.075% (BROMFENAC) SOLUTION/ DROPS [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20230415_144a5072-341b-4591-8705-773b63044bcc.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 |
|---|
| 49708-754-41 | 49708075441 | 1 POUCH in 1 CARTON (49708-754-41) / 1 BOTTLE, DROPPER in 1 POUCH / 5 mL in 1 BOTTLE, DROPPER | 1 pouch | 2016-05-01 | 0000-00-00 | No | No | Current |