difluprednate ophthalmic

Generic: difluprednate ophthalmic

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

Drug Facts

Product Profile

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

difluprednate .5 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-6000
Product ID 0781-6000_6ae7a5b2-4844-4a63-a95e-8dd76c1e3653
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022212
Listing Expiration 2026-12-31
Marketing Start 2013-05-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07816000
Hyphenated Format 0781-6000

Supplemental Identifiers

RxCUI
804544
UPC
0307816000782
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 difluprednate ophthalmic (source: ndc)
Generic Name difluprednate ophthalmic (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 (0781-6000-78) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

0781-6000-78 1 BOTTLE in 1 CARTON (0781-6000-78) / 5 mL in 1 BOTTLE

Ingredients (1)

difluprednate (.5 mg/mL)

Linked Drug Pages (1)

Difluprednate Ophthalmic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "6ae7a5b2-4844-4a63-a95e-8dd76c1e3653", "openfda": {"upc": ["0307816000782"], "unii": ["S8A06QG2QE"], "rxcui": ["804544"], "spl_set_id": ["0f60b857-7898-4a9e-935c-a9ddf0eb9194"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0781-6000-78)  / 5 mL in 1 BOTTLE", "package_ndc": "0781-6000-78", "marketing_start_date": "20210915"}], "brand_name": "Difluprednate Ophthalmic", "product_id": "0781-6000_6ae7a5b2-4844-4a63-a95e-8dd76c1e3653", "dosage_form": "EMULSION", "product_ndc": "0781-6000", "generic_name": "Difluprednate Ophthalmic", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Difluprednate Ophthalmic", "active_ingredients": [{"name": "DIFLUPREDNATE", "strength": ".5 mg/mL"}], "application_number": "NDA022212", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20130515", "listing_expiration_date": "20261231"}