clobetasol propionate

Generic: clobetasol propionate

Labeler: eyenovia, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name clobetasol propionate
Generic Name clobetasol propionate
Labeler eyenovia, inc.
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

clobetasol propionate .5 mg/mL

Manufacturer
Eyenovia, Inc.

Identifiers & Regulatory

Product NDC 81046-0319
Product ID 81046-0319_32e1b12d-ed8c-33a3-e063-6294a90a3109
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA218158
Listing Expiration 2026-12-31
Marketing Start 2024-03-25

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 810460319
Hyphenated Format 81046-0319

Supplemental Identifiers

RxCUI
2683740
UNII
779619577M

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 clobetasol propionate (source: ndc)
Generic Name clobetasol propionate (source: ndc)
Application Number NDA218158 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (81046-0319-1) / 3.5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

81046-0319-1 1 BOTTLE, DROPPER in 1 CARTON (81046-0319-1) / 3.5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

clobetasol propionate (.5 mg/mL)

Linked Drug Pages (1)

CLOBETASOL PROPIONATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "32e1b12d-ed8c-33a3-e063-6294a90a3109", "openfda": {"unii": ["779619577M"], "rxcui": ["2683740"], "spl_set_id": ["7687c980-7006-4222-80b9-c32773772d3e"], "manufacturer_name": ["Eyenovia, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (81046-0319-1)  / 3.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "81046-0319-1", "marketing_start_date": "20240325"}], "brand_name": "CLOBETASOL PROPIONATE", "product_id": "81046-0319_32e1b12d-ed8c-33a3-e063-6294a90a3109", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "81046-0319", "generic_name": "CLOBETASOL PROPIONATE", "labeler_name": "Eyenovia, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLOBETASOL PROPIONATE", "active_ingredients": [{"name": "CLOBETASOL PROPIONATE", "strength": ".5 mg/mL"}], "application_number": "NDA218158", "marketing_category": "NDA", "marketing_start_date": "20240325", "listing_expiration_date": "20261231"}