difluprednate ophthalmic emulsion

Generic: difluprednate ophthalmic

Labeler: dr. reddy's laboratories inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name difluprednate ophthalmic emulsion
Generic Name difluprednate ophthalmic
Labeler dr. reddy's laboratories inc.
Dosage Form EMULSION
Routes
OPHTHALMIC
Active Ingredients

difluprednate .5 mg/mL

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-588
Product ID 43598-588_acd98bc6-dcd8-d0f5-9b9a-d2652e0c37c6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214894
Listing Expiration 2026-12-31
Marketing Start 2022-12-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598588
Hyphenated Format 43598-588

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 ophthalmic emulsion (source: ndc)
Generic Name difluprednate ophthalmic (source: ndc)
Application Number ANDA214894 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (43598-588-11) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

43598-588-11 1 BOTTLE in 1 CARTON (43598-588-11) / 5 mL in 1 BOTTLE

Ingredients (1)

difluprednate (.5 mg/mL)

Linked Drug Pages (1)

Difluprednate Ophthalmic Emulsion ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "acd98bc6-dcd8-d0f5-9b9a-d2652e0c37c6", "openfda": {"unii": ["S8A06QG2QE"], "rxcui": ["804544"], "spl_set_id": ["12803630-3196-1b3e-28e4-a598a742ef1a"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (43598-588-11)  / 5 mL in 1 BOTTLE", "package_ndc": "43598-588-11", "marketing_start_date": "20221225"}], "brand_name": "Difluprednate Ophthalmic Emulsion", "product_id": "43598-588_acd98bc6-dcd8-d0f5-9b9a-d2652e0c37c6", "dosage_form": "EMULSION", "product_ndc": "43598-588", "generic_name": "Difluprednate Ophthalmic", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Difluprednate Ophthalmic Emulsion", "active_ingredients": [{"name": "DIFLUPREDNATE", "strength": ".5 mg/mL"}], "application_number": "ANDA214894", "marketing_category": "ANDA", "marketing_start_date": "20221225", "listing_expiration_date": "20261231"}