bromfenac

Generic: bromfenac

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bromfenac
Generic Name bromfenac
Labeler gland pharma limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

bromfenac sodium .9 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-313
Product ID 68083-313_4aed36ae-5bc7-4be8-a511-a9126050e7de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211029
Listing Expiration 2026-12-31
Marketing Start 2020-03-17

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 68083313
Hyphenated Format 68083-313

Supplemental Identifiers

RxCUI
578018
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 bromfenac (source: ndc)
Generic Name bromfenac (source: ndc)
Application Number ANDA211029 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .9 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (68083-313-01) / 1.7 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

68083-313-01 1 BOTTLE, DROPPER in 1 CARTON (68083-313-01) / 1.7 mL in 1 BOTTLE, DROPPER

Ingredients (1)

bromfenac sodium (.9 mg/mL)

Linked Drug Pages (1)

BROMFENAC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "4aed36ae-5bc7-4be8-a511-a9126050e7de", "openfda": {"unii": ["8ECV571Y37"], "rxcui": ["578018"], "spl_set_id": ["2120380c-81e6-43ce-9211-aad1993b9be2"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (68083-313-01)  / 1.7 mL in 1 BOTTLE, DROPPER", "package_ndc": "68083-313-01", "marketing_start_date": "20200317"}], "brand_name": "BROMFENAC", "product_id": "68083-313_4aed36ae-5bc7-4be8-a511-a9126050e7de", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "68083-313", "generic_name": "Bromfenac", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BROMFENAC", "active_ingredients": [{"name": "BROMFENAC SODIUM", "strength": ".9 mg/mL"}], "application_number": "ANDA211029", "marketing_category": "ANDA", "marketing_start_date": "20200317", "listing_expiration_date": "20261231"}