Prescription drug · ANDA
Bromfenac NDC 65862-789
Bromfenac sodium .9 mg/mL · Solution/ drops · Ophthalmic · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-789-17 | 65862078917 | 1 BOTTLE in 1 CARTON (65862-789-17) / 1.7 mL in 1 BOTTLEMarketed from Mar 18, 2022 |
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 — .9 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204813
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 65862-789_56d497cf-0ffc-4f15-8fb6-e66a56f1dfe1SPL ID 56d497cf-0ffc-4f15-8fb6-e66a56f1dfe1SPL set ID fa40fc6b-1bd0-4496-b53a-8b3e1c122a50RxCUI 578018UNII 8ECV571Y37UPC 0365862789174
- 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
N465862078917followed by a unit qualifier and the quantityPackage 65862-0789-17. 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 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac ophthalmic solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction (1) .
Excerpt only. Read the full label for complete information.