bromsite 0.075%

Generic: bromfenac

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name bromsite 0.075%
Generic Name bromfenac
Labeler sun pharmaceutical industries, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

bromfenac sodium .76 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 49708-754
Product ID 49708-754_47daa628-c56f-1e9d-e063-6294a90a3d33
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206911
Listing Expiration 2027-12-31
Marketing Start 2016-05-01

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49708754
Hyphenated Format 49708-754

Supplemental Identifiers

RxCUI
1790141 1790146
UNII
8ECV571Y37

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bromsite 0.075% (source: ndc)
Generic Name bromfenac (source: ndc)
Application Number NDA206911 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .76 mg/mL
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (49708-754-41) / 1 BOTTLE, DROPPER in 1 POUCH / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

49708-754-41 1 POUCH in 1 CARTON (49708-754-41) / 1 BOTTLE, DROPPER in 1 POUCH / 5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

bromfenac sodium (.76 mg/mL)

Linked Drug Pages (1)

BROMSITE 0.075% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "47daa628-c56f-1e9d-e063-6294a90a3d33", "openfda": {"unii": ["8ECV571Y37"], "rxcui": ["1790141", "1790146"], "spl_set_id": ["144a5072-341b-4591-8705-773b63044bcc"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (49708-754-41)  / 1 BOTTLE, DROPPER in 1 POUCH / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "49708-754-41", "marketing_start_date": "20160501"}], "brand_name": "BROMSITE 0.075%", "product_id": "49708-754_47daa628-c56f-1e9d-e063-6294a90a3d33", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "49708-754", "generic_name": "bromfenac", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BROMSITE", "brand_name_suffix": "0.075%", "active_ingredients": [{"name": "BROMFENAC SODIUM", "strength": ".76 mg/mL"}], "application_number": "NDA206911", "marketing_category": "NDA", "marketing_start_date": "20160501", "listing_expiration_date": "20271231"}