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NDC 68180-0433-02 bromfenac sodium 0.805 mg/mL Details
bromfenac sodium 0.805 mg/mL
bromfenac sodium is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is BROMFENAC SODIUM.
MedlinePlus Drug Summary
Bromfenac ophthalmic is used to treat eye swelling and redness (inflammation) and pain that can occur after cataract surgery. Bromfenac ophthalmic is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the release of certain natural substances that cause pain and swelling.
Related Packages: 68180-0433-02Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Bromfenac Ophthalmic
Product Information
| NDC | 68180-0433 |
|---|---|
| Product ID | 68180-433_61d0e0ec-a82b-4711-8b03-5c40fc33ae22 |
| Associated GPIs | |
| GCN Sequence Number | 070835 |
| GCN Sequence Number Description | bromfenac sodium DROPS 0.07 % OPHTHALMIC |
| HIC3 | Q6P |
| HIC3 Description | EYE ANTI-INFLAMMATORY AGENTS |
| GCN | 34487 |
| HICL Sequence Number | 013633 |
| HICL Sequence Number Description | BROMFENAC SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | bromfenac sodium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | bromfenac sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION/ DROPS |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 0.805 |
| Active Ingredient Units | mg/mL |
| Substance Name | BROMFENAC SODIUM |
| Labeler Name | Lupin Pharmaceuticals, Inc. |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA206027 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68180-0433-02 (68180043302)
| NDC Package Code | 68180-433-02 |
|---|---|
| Billing NDC | 68180043302 |
| Package | 1 BOTTLE, DROPPER in 1 CARTON (68180-433-02) / 3 mL in 1 BOTTLE, DROPPER |
| Marketing Start Date | 2023-12-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |