NDC codes

FDA NDC Directory
Product NDC (as listed)49708-755Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49708-0755Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
49708-755-4149708075541497080755411 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

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

N449708075541 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under NDA 206911
ProductStrengthForm · routeLabelerProduct NDC
Bromsite 0.075%bromfenacBromfenac sodium .76 mg/mLSolution/ dropsOphthalmicSun Pharmaceutical Industries, Inc.49708-754

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