BROMFENAC
- Product NDC
- 68083-313
- 11-digit product format
- 680830313
- Labeler code
- 68083
- Product ID
- 68083-313_4aed36ae-5bc7-4be8-a511-a9126050e7de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bromfenac
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Gland Pharma Limited
- Application
- ANDA211029
- Marketing category
- ANDA
- Marketing start
- 2020-03-17
- 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 |
|---|
| 68083-313-01 | BROMFENAC | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 3 |
| 68083-313-01 | BROMFENAC | 1.7 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 1.7 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-313 | BROMFENAC SOLUTION/ DROPS [GLAND PHARMA LIMITED] | 3 | Current NDC, Legacy NDC, 2 package rows | 20200401_2120380c-81e6-43ce-9211-aad1993b9be2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68083-313-01 | 68083031301 | 1 BOTTLE, DROPPER in 1 CARTON (68083-313-01) / 1.7 mL in 1 BOTTLE, DROPPER | 2020-03-17 | 0000-00-00 | No | No | Current |