difluprednate

Generic: difluprednate ophthalmic

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name difluprednate
Generic Name difluprednate ophthalmic
Labeler alembic pharmaceuticals limited
Dosage Form EMULSION
Routes
OPHTHALMIC
Active Ingredients

difluprednate .5 mg/mL

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-750
Product ID 46708-750_71121026-1496-4154-b61b-9afe9b62bf2a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213774
Listing Expiration 2027-12-31
Marketing Start 2026-01-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708750
Hyphenated Format 46708-750

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 ANDA213774 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (46708-750-05) / 5 mL in 1 BOTTLE
source: ndc

Packages (1)

46708-750-05 1 BOTTLE in 1 CARTON (46708-750-05) / 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": "71121026-1496-4154-b61b-9afe9b62bf2a", "openfda": {"unii": ["S8A06QG2QE"], "rxcui": ["804544"], "spl_set_id": ["71121026-1496-4154-b61b-9afe9b62bf2a"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (46708-750-05)  / 5 mL in 1 BOTTLE", "package_ndc": "46708-750-05", "marketing_start_date": "20260126"}], "brand_name": "Difluprednate", "product_id": "46708-750_71121026-1496-4154-b61b-9afe9b62bf2a", "dosage_form": "EMULSION", "product_ndc": "46708-750", "generic_name": "difluprednate ophthalmic", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Difluprednate", "active_ingredients": [{"name": "DIFLUPREDNATE", "strength": ".5 mg/mL"}], "application_number": "ANDA213774", "marketing_category": "ANDA", "marketing_start_date": "20260126", "listing_expiration_date": "20271231"}