difluprednate

Generic: difluprednate

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name difluprednate
Generic Name difluprednate
Labeler cipla usa inc.
Dosage Form EMULSION
Routes
OPHTHALMIC
Active Ingredients

difluprednate .5 mg/mL

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-341
Product ID 69097-341_825a55a7-ffdf-4fde-bbb2-486cbd16e602
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211776
Listing Expiration 2026-12-31
Marketing Start 2021-08-09

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097341
Hyphenated Format 69097-341

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 ANDA211776 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69097-341-35) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

69097-341-35 1 BOTTLE in 1 CARTON (69097-341-35) / 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": "825a55a7-ffdf-4fde-bbb2-486cbd16e602", "openfda": {"unii": ["S8A06QG2QE"], "rxcui": ["804544"], "spl_set_id": ["8a7254de-a7a2-476d-9295-c41926267ec9"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69097-341-35)  / 5 mL in 1 BOTTLE", "package_ndc": "69097-341-35", "marketing_start_date": "20210809"}], "brand_name": "DIFLUPREDNATE", "product_id": "69097-341_825a55a7-ffdf-4fde-bbb2-486cbd16e602", "dosage_form": "EMULSION", "product_ndc": "69097-341", "generic_name": "DIFLUPREDNATE", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DIFLUPREDNATE", "active_ingredients": [{"name": "DIFLUPREDNATE", "strength": ".5 mg/mL"}], "application_number": "ANDA211776", "marketing_category": "ANDA", "marketing_start_date": "20210809", "listing_expiration_date": "20261231"}