Prescription drug · ANDA
Bromfenac NDC 68180-434
Bromfenac sodium .75 mg/mL · Solution/ drops · Ophthalmic · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-434-01 | 68180043401 | 1 BOTTLE in 1 CARTON (68180-434-01) / 5 mL in 1 BOTTLEMarketed from Feb 12, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Bromfenac
- Generic name (nonproprietary)
- bromfenac
- Active ingredients
- Bromfenac sodium — .75 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211239
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 68180-434_bde2565a-075e-4910-874b-9737d0ed9cccSPL ID bde2565a-075e-4910-874b-9737d0ed9cccSPL set ID 2b2621e7-a69e-4286-a7e7-0fc31a91fe29RxCUI 1790141UNII 8ECV571Y37
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468180043401followed by a unit qualifier and the quantityPackage 68180-0434-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Bromfenac ophthalmic solution, 0.075% is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. Bromfenac ophthalmic solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. ( 1 )
Excerpt only. Read the full label for complete information.
- openFDA data updated
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