Home NDC 50383-270 Clobetasol Propionate
Product NDC 50383-270
11-digit product format 503830270
Labeler code 50383
Product ID 50383-270_552f5be6-bc56-4f8d-99c0-16d3de609ef4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clobetasol Propionate
Dosage form EMULSION
Route TOPICAL
Labeler Akorn
Application ANDA075325
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 A075325-001 EMBELINE E CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 1998-12-24
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 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 a50c72e98297…
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLOBETASOL PROPIONATE ACTIVE INGREDIENT 779619577M CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 CLOBETASOL ACTIVE MOIETY ADN79D536H CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 CETETH-20 INACTIVE INGREDIENT I835H2IHHX CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 DIMETHICONE 350 INACTIVE INGREDIENT 2Y53S6ATLU CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 IMIDUREA INACTIVE INGREDIENT M629807ATL CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 CLOBETASOL PROPIONATE ACTIVE INGREDIENT 779619577M CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1 CLOBETASOL ACTIVE MOIETY ADN79D536H CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1 CETETH-20 INACTIVE INGREDIENT I835H2IHHX CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1 DIMETHICONE 350 INACTIVE INGREDIENT 2Y53S6ATLU CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1 IMIDUREA INACTIVE INGREDIENT M629807ATL CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1
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 50383-270-15 50383027015 1 TUBE in 1 CARTON (50383-270-15) > 15 g in 1 TUBE 1 tube 2010-06-07 0000-00-00 No No Current 50383-270-30 50383027030 1 TUBE in 1 CAPSULE (50383-270-30) > 30 g in 1 TUBE 1 tube 2010-06-07 0000-00-00 No No Current 50383-270-60 50383027060 1 TUBE in 1 CARTON (50383-270-60) > 60 g in 1 TUBE 1 tube 2010-06-07 0000-00-00 No No Current