difluprednate

Generic: difluprednate ophthalmic

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name difluprednate
Generic Name difluprednate ophthalmic
Labeler amneal pharmaceuticals ny llc
Dosage Form EMULSION
Routes
OPHTHALMIC
Active Ingredients

difluprednate .5 mg/mL

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1380
Product ID 69238-1380_18ce4ee4-f7ba-47f7-b202-15349b00f18d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211526
Listing Expiration 2026-12-31
Marketing Start 2021-11-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692381380
Hyphenated Format 69238-1380

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 ophthalmic (source: ndc)
Application Number ANDA211526 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69238-1380-3) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

69238-1380-3 1 BOTTLE in 1 CARTON (69238-1380-3) / 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": "18ce4ee4-f7ba-47f7-b202-15349b00f18d", "openfda": {"unii": ["S8A06QG2QE"], "rxcui": ["804544"], "spl_set_id": ["3612ff2a-c4bf-4322-b5bc-e7b867575321"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69238-1380-3)  / 5 mL in 1 BOTTLE", "package_ndc": "69238-1380-3", "marketing_start_date": "20211118"}], "brand_name": "Difluprednate", "product_id": "69238-1380_18ce4ee4-f7ba-47f7-b202-15349b00f18d", "dosage_form": "EMULSION", "product_ndc": "69238-1380", "generic_name": "Difluprednate ophthalmic", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Difluprednate", "active_ingredients": [{"name": "DIFLUPREDNATE", "strength": ".5 mg/mL"}], "application_number": "ANDA211526", "marketing_category": "ANDA", "marketing_start_date": "20211118", "listing_expiration_date": "20261231"}