Home NDC 68462-299 Alclometasone Dipropionate
Product NDC 68462-299
11-digit product format 684620299
Labeler code 68462
Product ID 68462-299_098145f1-cb92-4222-8069-72fbf92fce9f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alclometasone Dipropionate
Dosage form OINTMENT
Route TOPICAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA079227
Marketing category ANDA
Marketing start 2009-07-30
Substance ALCLOMETASONE DIPROPIONATE
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 43 .
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 A079227-001 ALCLOMETASONE DIPROPIONATE ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL 2009-07-30
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.
Product history page 1 of 2 · 43 observed 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 2026-09-14 22:38:34 2026-08 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL 2009-07-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL 2009-07-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL 2009-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL 2009-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL 2009-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079227-001 ALCLOMETASONE DIPROPIONATE 0.05% OINTMENT / TOPICAL AB 2009-07-30 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Alclometasone Dipropionate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALCLOMETASONE DIPROPIONATE .5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S56PQL4N1V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855474 Internal RxNorm lookup 855480 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 68462-299-17 Alclometasone Dipropionate 15 g in 1 TUBE OINTMENT 15 15 68462-299-47 Alclometasone Dipropionate 45 g in 1 TUBE OINTMENT 45 15 68462-299-65 Alclometasone Dipropionate 60 g in 1 TUBE OINTMENT 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 68462-299 ALCLOMETASONE DIPROPIONATE CREAM ALCLOMETASONE DIPROPIONATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 15 Current NDC, Legacy NDC, 3 package rows 20240118_63e635e0-65d8-4b30-9f2a-ab16deba90bd.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 68462-299-17 68462029917 15 g in 1 TUBE (68462-299-17) 15 g 2009-07-30 0000-00-00 No No Current 68462-299-47 68462029947 45 g in 1 TUBE (68462-299-47) 45 g 2009-07-30 0000-00-00 No No Current 68462-299-65 68462029965 60 g in 1 TUBE (68462-299-65) 60 g 2009-07-30 0000-00-00 No No Current