Home NDC 51672-1297-2 Clobetasol Propionate
Product NDC 51672-1297
Requested package NDC 51672-1297-2
11-digit product format 516721297
Labeler code 51672
Product ID 51672-1297_3cf4526e-e856-d065-e063-6394a90a12bc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clobetasol Propionate
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA075633
Marketing category ANDA
Marketing start 2000-05-17
Substance CLOBETASOL 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 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 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB2 2000-05-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075633-001 AB2
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 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A075633-001 AB2 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Clobetasol Propionate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOBETASOL PROPIONATE .5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 779619577M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1992281 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-1297-1 Clobetasol Propionate 1 in 1 CARTON CREAM 1 8 51672-1297-1 Clobetasol Propionate 15 g in 1 TUBE CREAM 15 8 51672-1297-2 Clobetasol Propionate 30 g in 1 TUBE CREAM 30 8 51672-1297-2 Clobetasol Propionate 1 in 1 CARTON CREAM 1 8 51672-1297-3 Clobetasol Propionate 1 in 1 CARTON CREAM 1 8 51672-1297-3 Clobetasol Propionate 60 g in 1 TUBE CREAM 60 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Clobetasol Propionate ACTIVE INGREDIENT 779619577M CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 Clobetasol ACTIVE MOIETY ADN79D536H CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 ceteth-20 INACTIVE INGREDIENT I835H2IHHX CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 cetostearyl alcohol INACTIVE INGREDIENT 2DMT128M1S CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 dimethicone 350 INACTIVE INGREDIENT 2Y53S6ATLU CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 imidurea INACTIVE INGREDIENT M629807ATL CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 isopropyl myristate INACTIVE INGREDIENT 0RE8K4LNJS CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1297 CLOBETASOL PROPIONATE CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.] 7 Current NDC, Legacy NDC, 6 package rows 20250524_91571297-03ad-441e-8ec6-f78c21fbe5e8.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 51672-1297-2 51672129702 1 TUBE in 1 CARTON (51672-1297-2) / 30 g in 1 TUBE 1 tube 2000-05-17 0000-00-00 No No Current