Prescription drug · ANDA
Bromfenac Ophthalmic Solution, 0.07% (Bromfenac sodium) NDC 60505-1006
Bromfenac sodium .7 mg/mL · Solution/ drops · Ophthalmic · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-1006-1 | 6050510060160505100601 | 1 BOTTLE, DROPPER in 1 CARTON (60505-1006-1) / 1.6 mL in 1 BOTTLE, DROPPERMarketed from Jul 11, 2024 | |
| 60505-1006-2 | 6050510060260505100602 | 1 BOTTLE, DROPPER in 1 CARTON (60505-1006-2) / 3 mL in 1 BOTTLE, DROPPERMarketed from Jul 11, 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 Ophthalmic Solution, 0.07%
- Generic name (nonproprietary)
- bromfenac sodium
- Active ingredients
- Bromfenac sodium — .7 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Apotex Corp.NDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207334
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 60505-1006_5b8089f6-3ea2-fddd-00c6-aa4ed96b8cabSPL ID 5b8089f6-3ea2-fddd-00c6-aa4ed96b8cabSPL set ID 4246c669-3c2a-2a2b-3b1c-696deb4ab519RxCUI 1375917UNII 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
N460505100601followed by a unit qualifier and the quantityPackage 60505-1006-01. 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, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac Ophthalmic Solution, 0.07% 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 60505-1006
- What is NDC 60505-1006?
- 60505-1006 is the product NDC for Bromfenac Ophthalmic Solution, 0.07%, Bromfenac sodium .7 mg/mL solution/ drops, listed with the FDA by Apotex Corp.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bromfenac Ophthalmic Solution, 0.07% (Bromfenac Sodium).
- What is the active ingredient?
- Bromfenac sodium.
- Who is the labeler?
- Apotex Corp., NDC labeler code 60505. 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, 0.07%?
- 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.