Home NDC 50383-266 Clobetasol Propionate
Product NDC 50383-266
11-digit product format 503830266
Labeler code 50383
Product ID 50383-266_11d732ce-7ab6-470d-a7f0-ca8fb2024d97
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clobetasol Propionate
Dosage form SOLUTION
Route TOPICAL
Labeler Akorn
Application ANDA074222
Marketing category ANDA
Marketing start 2010-06-07
Marketing end 0000-00-00
Substance CLOBETASOL PROPIONATE
Active strength 0 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074222-001 EMBELINE CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 1995-12-06
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A074222-001 EMBELINE 0.05% SOLUTION / TOPICAL 1995-12-06 a50c72e98297…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLOBETASOL PROPIONATE ACTIVE INGREDIENT 779619577M CLOBETASOL PROPIONATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 2 CLOBETASOL PROPIONATE ACTIVE INGREDIENT 779619577M CLOBETASOL PROPIONATE SOLUTION [HI-TECH PHARMACAL CO., INC.] 2 CLOBETASOL ACTIVE MOIETY ADN79D536H CLOBETASOL PROPIONATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 2 CLOBETASOL ACTIVE MOIETY ADN79D536H CLOBETASOL PROPIONATE SOLUTION [HI-TECH PHARMACAL CO., INC.] 2 CARBOMER HOMOPOLYMER TYPE B INACTIVE INGREDIENT HHT01ZNK31 CLOBETASOL PROPIONATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 2 CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT K61870Z308 CLOBETASOL PROPIONATE SOLUTION [HI-TECH PHARMACAL CO., INC.] 2 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 CLOBETASOL PROPIONATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 2 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 CLOBETASOL PROPIONATE SOLUTION [HI-TECH PHARMACAL CO., INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CLOBETASOL PROPIONATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CLOBETASOL PROPIONATE SOLUTION [HI-TECH PHARMACAL CO., INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R CLOBETASOL PROPIONATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R CLOBETASOL PROPIONATE SOLUTION [HI-TECH PHARMACAL CO., INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50383-266 CLOBETASOL PROPIONATE SOLUTION [AKORN] 6 Legacy NDC 20220312_d2a1bcea-66db-4dd9-b586-7beef185a754.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50383-266-25 50383026625 1 BOTTLE in 1 CARTON (50383-266-25) > 25 mL in 1 BOTTLE 1 bottle 2010-06-07 0000-00-00 No No Current 50383-266-50 50383026650 1 BOTTLE in 1 CARTON (50383-266-50) > 50 mL in 1 BOTTLE 1 bottle 2010-06-07 0000-00-00 No No Current