Prescription drug · ANDA
Bromfenac Ophthalmic Solution 0.09% NDC 62332-508
Bromfenac sodium 1.035 mg/mL · Solution/ drops · Ophthalmic · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-508-17 | 6233205081762332050817 | 1 BOTTLE in 1 CARTON (62332-508-17) / 1.7 mL in 1 BOTTLEMarketed from Jun 21, 2019 |
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 Ophthalmic Solution 0.09%
- Generic name (nonproprietary)
- bromfenac ophthalmic solution 0.09%
- Active ingredients
- Bromfenac sodium — 1.035 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Alembic Pharmaceuticals Inc.NDC labeler code 62332
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210560
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 62332-508_824d37d0-e25f-4df8-be0e-d9a65046fc10SPL ID 824d37d0-e25f-4df8-be0e-d9a65046fc10SPL set ID 225070ee-d862-4d41-84b8-5bd7a8a03fd7RxCUI 578018UNII 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
N462332050817followed by a unit qualifier and the quantityPackage 62332-0508-17. 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 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.
Excerpt only. Read the full label for complete information.
About NDC 62332-508
- What is NDC 62332-508?
- 62332-508 is the product NDC for Bromfenac Ophthalmic Solution 0.09%, Bromfenac sodium 1.035 mg/mL solution/ drops, listed with the FDA by Alembic Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bromfenac Ophthalmic Solution 0.09%.
- What is the active ingredient?
- Bromfenac sodium.
- Who is the labeler?
- Alembic Pharmaceuticals Inc., NDC labeler code 62332. 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 Ophthalmic Solution 0.09%?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 210560
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| bromfenac | Bromfenac sodium 1.035 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Limited | 46708-508 |