difluprednate

Generic: difluprednate

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name difluprednate
Generic Name difluprednate
Labeler upsher-smith laboratories, llc
Dosage Form EMULSION
Routes
OPHTHALMIC
Active Ingredients

difluprednate .5 mg/mL

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-6054
Product ID 0832-6054_4af796ab-94c3-c22a-e063-6294a90abcb3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218191
Listing Expiration 2027-12-31
Marketing Start 2025-02-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 08326054
Hyphenated Format 0832-6054

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 ANDA218191 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0832-6054-05) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

0832-6054-05 1 BOTTLE in 1 CARTON (0832-6054-05) / 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": "4af796ab-94c3-c22a-e063-6294a90abcb3", "openfda": {"unii": ["S8A06QG2QE"], "rxcui": ["804544"], "spl_set_id": ["ce8c1d56-771e-45da-8a19-5f881f993738"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0832-6054-05)  / 5 mL in 1 BOTTLE", "package_ndc": "0832-6054-05", "marketing_start_date": "20250821"}], "brand_name": "Difluprednate", "product_id": "0832-6054_4af796ab-94c3-c22a-e063-6294a90abcb3", "dosage_form": "EMULSION", "product_ndc": "0832-6054", "generic_name": "Difluprednate", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Difluprednate", "active_ingredients": [{"name": "DIFLUPREDNATE", "strength": ".5 mg/mL"}], "application_number": "ANDA218191", "marketing_category": "ANDA", "marketing_start_date": "20250221", "listing_expiration_date": "20271231"}