Home NDC 50383-268 Clobetasol Propionate
Product NDC 50383-268
11-digit product format 503830268
Labeler code 50383
Product ID 50383-268_e5680f3e-ab53-4716-a708-3e12e118a867
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clobetasol Propionate
Dosage form OINTMENT
Route TOPICAL
Labeler Akorn
Application ANDA074221
Marketing category ANDA
Marketing start 2010-06-07
Marketing end 0000-00-00
Substance CLOBETASOL PROPIONATE
Active strength 1 mg/g
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 A074221-001 EMBELINE CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL 1995-03-31
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 A074221-001 EMBELINE 0.05% OINTMENT / TOPICAL 1995-03-31 a50c72e98297…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 50383-268-15 2024-01-30 C162847 48780-1 1030e365-156f-111a-e063-dadaa90a10e2 Clobetasol Propionate Cream, USP, 0.05% Clobetasol Propionate Ointment, USP, 0.05% 50383-268-30 2024-01-30 C162847 48780-1 1030e365-156f-111a-e063-dadaa90a10e2 Clobetasol Propionate Cream, USP, 0.05% Clobetasol Propionate Ointment, USP, 0.05% 50383-268-45 2024-01-30 C162847 48780-1 1030e365-156f-111a-e063-dadaa90a10e2 Clobetasol Propionate Cream, USP, 0.05% Clobetasol Propionate Ointment, USP, 0.05% 50383-268-60 2024-01-30 C162847 48780-1 1030e365-156f-111a-e063-dadaa90a10e2 Clobetasol Propionate Cream, USP, 0.05% Clobetasol Propionate Ointment, USP, 0.05%
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLOBETASOL PROPIONATE ACTIVE INGREDIENT 779619577M CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 CLOBETASOL ACTIVE MOIETY ADN79D536H CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 GLYCOL STEARATE INACTIVE INGREDIENT 0324G66D0E CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 LANOLIN INACTIVE INGREDIENT 7EV65EAW6H CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 PEG-8 STEARATE INACTIVE INGREDIENT 2P9L47VI5E CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 SORBITAN SESQUIOLEATE INACTIVE INGREDIENT 0W8RRI5W5A CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 CLOBETASOL PROPIONATE ACTIVE INGREDIENT 779619577M CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 CLOBETASOL ACTIVE MOIETY ADN79D536H CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 GLYCOL STEARATE INACTIVE INGREDIENT 0324G66D0E CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 LANOLIN INACTIVE INGREDIENT 7EV65EAW6H CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 PEG-8 STEARATE INACTIVE INGREDIENT 2P9L47VI5E CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 SORBITAN SESQUIOLEATE INACTIVE INGREDIENT 0W8RRI5W5A CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50383-268 CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [AKORN] 6 Legacy NDC 20221202_fb29b17b-96af-4a78-bc91-83cf8c5c2b1d.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50383-268-15 50383026815 1 TUBE in 1 CARTON (50383-268-15) > 15 g in 1 TUBE 1 tube 2010-06-07 0000-00-00 No No Current 50383-268-30 50383026830 1 TUBE in 1 CARTON (50383-268-30) > 30 g in 1 TUBE 1 tube 2010-06-07 0000-00-00 No No Current 50383-268-45 50383026845 1 TUBE in 1 CARTON (50383-268-45) > 45 g in 1 TUBE 1 tube 2010-06-07 0000-00-00 No No Current 50383-268-60 50383026860 1 TUBE in 1 CARTON (50383-268-60) > 60 g in 1 TUBE 1 tube 2010-06-07 0000-00-00 No No Current