Home NDC 68462-300-17 Alclometasone Dipropionate
Product NDC 68462-300
Requested package NDC 68462-300-17
11-digit product format 684620300
Labeler code 68462
Product ID 68462-300_12f7d6b4-e87b-4a4d-b642-4ec8853a6dc2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alclometasone Dipropionate
Dosage form CREAM
Route TOPICAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA079061
Marketing category ANDA
Marketing start 2009-06-23
Marketing end 0000-00-00
Substance ALCLOMETASONE DIPROPIONATE
Active strength 1 mg/g
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
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 A079061-001 ALCLOMETASONE DIPROPIONATE ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL 2009-06-23
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 A079061-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL 2009-06-23 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.
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DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68462-300-17 Alclometasone Dipropionate 15 g in 1 TUBE CREAM 15 15 68462-300-47 Alclometasone Dipropionate 45 g in 1 TUBE CREAM 45 15 68462-300-65 Alclometasone Dipropionate 60 g in 1 TUBE CREAM 60 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALCLOMETASONE DIPROPIONATE ACTIVE INGREDIENT S56PQL4N1V ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 8 ALCLOMETASONE ACTIVE MOIETY 136H45TB7B ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 8 CETETH-20 INACTIVE INGREDIENT I835H2IHHX ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 8 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 8 CHLOROCRESOL INACTIVE INGREDIENT 36W53O7109 ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 8 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 8 HEXYLENE GLYCOL INACTIVE INGREDIENT KEH0A3F75J ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 8 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 8 PEG-25 PROPYLENE GLYCOL STEARATE INACTIVE INGREDIENT X21KPH4633 ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 8 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 8 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 8 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 8 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INACTIVE INGREDIENT 593YOG76RN ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 8 WATER INACTIVE INGREDIENT 059QF0KO0R ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 8 WHITE WAX INACTIVE INGREDIENT 7G1J5DA97F ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-300 ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 15 Legacy NDC, 3 package rows 20240118_63e635e0-65d8-4b30-9f2a-ab16deba90bd.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 68462-300-17 68462030017 15 g in 1 TUBE (68462-300-17) 15 g 2009-06-23 0000-00-00 No No Current