difluprednate

Generic: difluprednate

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name difluprednate
Generic Name difluprednate
Labeler mylan pharmaceuticals inc.
Dosage Form EMULSION
Routes
OPHTHALMIC
Active Ingredients

difluprednate .5 mg/mL

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-7518
Product ID 0378-7518_4a3b2649-ee3d-4648-91c8-912a8ba2e73c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212566
Listing Expiration 2026-12-31
Marketing Start 2025-09-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03787518
Hyphenated Format 0378-7518

Supplemental Identifiers

RxCUI
804544
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 (source: ndc)
Generic Name difluprednate (source: ndc)
Application Number ANDA212566 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0378-7518-35) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

0378-7518-35 1 BOTTLE in 1 CARTON (0378-7518-35) / 5 mL in 1 BOTTLE

Ingredients (1)

difluprednate (.5 mg/mL)

Linked Drug Pages (1)

Difluprednate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "4a3b2649-ee3d-4648-91c8-912a8ba2e73c", "openfda": {"unii": ["S8A06QG2QE"], "rxcui": ["804544"], "spl_set_id": ["4a3b2649-ee3d-4648-91c8-912a8ba2e73c"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0378-7518-35)  / 5 mL in 1 BOTTLE", "package_ndc": "0378-7518-35", "marketing_start_date": "20250926"}], "brand_name": "Difluprednate", "product_id": "0378-7518_4a3b2649-ee3d-4648-91c8-912a8ba2e73c", "dosage_form": "EMULSION", "product_ndc": "0378-7518", "generic_name": "Difluprednate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Difluprednate", "active_ingredients": [{"name": "DIFLUPREDNATE", "strength": ".5 mg/mL"}], "application_number": "ANDA212566", "marketing_category": "ANDA", "marketing_start_date": "20250926", "listing_expiration_date": "20261231"}