Prescription drug · NDA AUTHORIZED GENERIC
bromfenac 0.075% (Bromfenac) NDC 49708-755
Bromfenac sodium .76 mg/mL · Solution/ drops · Ophthalmic · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49708-755-41 | 4970807554149708075541 | 1 POUCH in 1 CARTON (49708-755-41) / 1 BOTTLE, DROPPER in 1 POUCH / 5 mL in 1 BOTTLE, DROPPERMarketed from Feb 7, 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 0.075%Suffix: 0.075%
- Generic name (nonproprietary)
- bromfenac
- Active ingredients
- Bromfenac sodium — .76 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 49708
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 206911
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 49708-755_47dae14d-3f32-0889-e063-6294a90aa707SPL ID 47dae14d-3f32-0889-e063-6294a90aa707SPL set ID 7d723a00-4822-4e04-aa22-21de22009d0aRxCUI 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
N449708075541followed by a unit qualifier and the quantityPackage 49708-0755-41. 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 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.
About NDC 49708-755
- What is NDC 49708-755?
- 49708-755 is the product NDC for bromfenac 0.075% (bromfenac), Bromfenac sodium .76 mg/mL solution/ drops, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- bromfenac 0.075% (Bromfenac).
- What is the active ingredient?
- Bromfenac sodium.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 49708. 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 0.075%?
- 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 NDA 206911
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 |
|---|---|---|---|---|
| Bromsite 0.075%bromfenac | Bromfenac sodium .76 mg/mL | Solution/ dropsOphthalmic | Sun Pharmaceutical Industries, Inc. | 49708-754 |