difluprednate

Generic: difluprednate

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name difluprednate
Generic Name difluprednate
Labeler caplin steriles limited
Dosage Form EMULSION
Routes
OPHTHALMIC
Active Ingredients

difluprednate .5 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-161
Product ID 65145-161_0f9a1987-6a04-4764-94e5-7053997c058b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219441
Listing Expiration 2026-12-31
Marketing Start 2024-12-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65145161
Hyphenated Format 65145-161

Supplemental Identifiers

RxCUI
804544
UPC
0365145161017
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 ANDA219441 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65145-161-01) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

65145-161-01 1 BOTTLE in 1 CARTON (65145-161-01) / 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": "0f9a1987-6a04-4764-94e5-7053997c058b", "openfda": {"upc": ["0365145161017"], "unii": ["S8A06QG2QE"], "rxcui": ["804544"], "spl_set_id": ["0f9a1987-6a04-4764-94e5-7053997c058b"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65145-161-01)  / 5 mL in 1 BOTTLE", "package_ndc": "65145-161-01", "marketing_start_date": "20241226"}], "brand_name": "Difluprednate", "product_id": "65145-161_0f9a1987-6a04-4764-94e5-7053997c058b", "dosage_form": "EMULSION", "product_ndc": "65145-161", "generic_name": "Difluprednate", "labeler_name": "Caplin Steriles Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Difluprednate", "active_ingredients": [{"name": "DIFLUPREDNATE", "strength": ".5 mg/mL"}], "application_number": "ANDA219441", "marketing_category": "ANDA", "marketing_start_date": "20241226", "listing_expiration_date": "20261231"}