Prescription drug · ANDA
Bromfenac NDC 60219-1526
Bromfenac sodium .7 mg/mL · Solution/ drops · Ophthalmic · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60219-1526-3 | 6021915260360219152603 | 1 BOTTLE, DROPPER in 1 CARTON (60219-1526-3) / 3 mL in 1 BOTTLE, DROPPERMarketed from Jul 31, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — .7 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Amneal Pharmaceuticals NY LLCNDC labeler code 60219
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210962
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 60219-1526_ba099985-d2c6-4a78-838f-9f2ae98f792aSPL ID ba099985-d2c6-4a78-838f-9f2ae98f792aSPL set ID 2c4eba0d-db55-4b54-a2ad-dfef1da9462fRxCUI 1375917UNII 8ECV571Y37UPC 0360219152632
- 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
N460219152603followed by a unit qualifier and the quantityPackage 60219-1526-03. 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, 0.07% 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 surgery. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 60219-1526
- What is NDC 60219-1526?
- 60219-1526 is the product NDC for Bromfenac, Bromfenac sodium .7 mg/mL solution/ drops, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bromfenac.
- What is the active ingredient?
- Bromfenac sodium.
- Who is the labeler?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 60219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bromfenac?
- 7 other product NDCs are listed under this name. See all Bromfenac NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bromfenac products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bromfenac | Bromfenac sodium .75 mg/mL | Solution/ dropsOphthalmic | Lupin Pharmaceuticals, Inc. | 68180-434 | 68180-0434-01 |
| Bromfenac | Bromfenac sodium .9 mg/mL | SolutionOphthalmic | Lupin Pharmaceuticals, Inc. | 68180-436 | 68180-0436-01 |
| Bromfenac | Bromfenac sodium 1.035 mg/mL | Solution/ dropsOphthalmic | ARMAS PHARMACEUTICALS INC. | 72485-649 | 72485-0649-71 |
| bromfenac | Bromfenac sodium 1.035 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Limited | 46708-508 | 46708-0508-17 |
| Bromfenac | Bromfenac sodium .9 mg/mL | Solution/ dropsOphthalmic | Aurobindo Pharma Limited | 65862-789 | 65862-0789-17 |
| Bromfenac | Bromfenac sodium .9 mg/mL | Solution/ dropsOphthalmic | Fosun Pharma USA Inc. | 72266-142 | 72266-0142-01 |
| Bromfenac | Bromfenac sodium .9 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-313 | 68083-0313-01 |