durezol

Generic: difluprednate

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name durezol
Generic Name difluprednate
Labeler sandoz inc
Dosage Form EMULSION
Routes
OPHTHALMIC
Active Ingredients

difluprednate .5 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 66758-086
Product ID 66758-086_4dadac60-2b25-486b-b716-86516821678c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022212
Listing Expiration 2026-12-31
Marketing Start 2011-01-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66758086
Hyphenated Format 66758-086

Supplemental Identifiers

RxCUI
804544 804547
UNII
S8A06QG2QE

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 durezol (source: ndc)
Generic Name difluprednate (source: ndc)
Application Number NDA022212 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (66758-086-75) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

66758-086-75 1 BOTTLE in 1 CARTON (66758-086-75) / 5 mL in 1 BOTTLE

Ingredients (1)

difluprednate (.5 mg/mL)

Linked Drug Pages (1)

DUREZOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "4dadac60-2b25-486b-b716-86516821678c", "openfda": {"unii": ["S8A06QG2QE"], "rxcui": ["804544", "804547"], "spl_set_id": ["ea520a27-f569-4b31-8bad-a25ad54b2caa"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (66758-086-75)  / 5 mL in 1 BOTTLE", "package_ndc": "66758-086-75", "marketing_start_date": "20241206"}], "brand_name": "DUREZOL", "product_id": "66758-086_4dadac60-2b25-486b-b716-86516821678c", "dosage_form": "EMULSION", "product_ndc": "66758-086", "generic_name": "difluprednate", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DUREZOL", "active_ingredients": [{"name": "DIFLUPREDNATE", "strength": ".5 mg/mL"}], "application_number": "NDA022212", "marketing_category": "NDA", "marketing_start_date": "20110125", "listing_expiration_date": "20261231"}