Home NDC 0713-0640 Halobetasol Propionate
Product NDC 0713-0640
11-digit product format 007130640
Labeler code 0713
Product ID 0713-0640_0acd2432-98e5-018e-e063-6294a90ad373
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Halobetasol Propionate
Dosage form CREAM
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA078162
Marketing category ANDA
Marketing start 2007-07-16
Substance HALOBETASOL PROPIONATE
Active strength .5 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Halobetasol Propionate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HALOBETASOL PROPIONATE .5 mg/g
Harmonized Identifiers# Field, Values table Field Values Unii 91A0K1TY3Z Rxcui 977990
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0713-0640-15 Halobetasol Propionate 15 g in 1 TUBE CREAM 15 8 0713-0640-86 Halobetasol Propionate 50 g in 1 TUBE CREAM 50 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Halobetasol Propionate ACTIVE INGREDIENT 91A0K1TY3Z HALOBETASOL PROPIONATE (HALOBETASOL PROPIONATE) CREAM [G&W LABORATORIES, INC.] 3 Halobetasol ACTIVE MOIETY 9P6159HM7T HALOBETASOL PROPIONATE (HALOBETASOL PROPIONATE) CREAM [G&W LABORATORIES, INC.] 3 Cetyl Alcohol INACTIVE INGREDIENT 936JST6JCN HALOBETASOL PROPIONATE (HALOBETASOL PROPIONATE) CREAM [G&W LABORATORIES, INC.] 3 Diazolidinyl Urea INACTIVE INGREDIENT H5RIZ3MPW4 HALOBETASOL PROPIONATE (HALOBETASOL PROPIONATE) CREAM [G&W LABORATORIES, INC.] 3 Glycerin INACTIVE INGREDIENT PDC6A3C0OX HALOBETASOL PROPIONATE (HALOBETASOL PROPIONATE) CREAM [G&W LABORATORIES, INC.] 3 Isopropyl Palmitate INACTIVE INGREDIENT 8CRQ2TH63M HALOBETASOL PROPIONATE (HALOBETASOL PROPIONATE) CREAM [G&W LABORATORIES, INC.] 3 Methylisothiazolinone INACTIVE INGREDIENT 229D0E1QFA HALOBETASOL PROPIONATE (HALOBETASOL PROPIONATE) CREAM [G&W LABORATORIES, INC.] 3 Water INACTIVE INGREDIENT 059QF0KO0R HALOBETASOL PROPIONATE (HALOBETASOL PROPIONATE) CREAM [G&W LABORATORIES, INC.] 3 Halobetasol Propionate ACTIVE INGREDIENT 91A0K1TY3Z HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] 1 Halobetasol ACTIVE MOIETY 9P6159HM7T HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] 1 Cetyl Alcohol INACTIVE INGREDIENT 936JST6JCN HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] 1 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] 1 Isopropyl Palmitate INACTIVE INGREDIENT 8CRQ2TH63M HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] 1 Methylisothiazolinone INACTIVE INGREDIENT 229D0E1QFA HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] 1 Water INACTIVE INGREDIENT 059QF0KO0R HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0640 HALOBETASOL PROPIONATE CREAM [COSETTE PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20231123_1f57aaae-8d5f-bfdf-08d6-495b84221311.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 0713-0640-15 00713064015 15 g in 1 TUBE (0713-0640-15) 15 g 2007-07-16 0000-00-00 No No Current 0713-0640-86 00713064086 50 g in 1 TUBE (0713-0640-86) 50 g 2007-07-16 0000-00-00 No No Current