Home NDC 0168-0263 Alclometasone Dipropionate
Product NDC 0168-0263
11-digit product format 001680263
Labeler code 0168
Product ID 0168-0263_901e10b7-2784-49c4-8e56-1c461aaad927
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name alclometasone dipropionate
Dosage form CREAM
Route TOPICAL
Labeler E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application ANDA076973
Marketing category ANDA
Marketing start 2005-07-12
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 A076973-001 ALCLOMETASONE DIPROPIONATE ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076973-001 AB
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 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076973-001 ALCLOMETASONE DIPROPIONATE 0.05% CREAM / TOPICAL AB RS 2005-07-12 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855474 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0168-0263-15 2025-08-11 ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05% 0168-0263-45 2025-08-11 ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05% 0168-0263-60 2025-08-11 ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05% 0168-0263-15 2025-07-29 ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05% 0168-0263-45 2025-07-29 ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05% 0168-0263-60 2025-07-29 ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05% 0168-0263-15 2020-09-16 ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05% 0168-0263-45 2020-09-16 ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05% 0168-0263-60 2020-09-16 ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05% 0168-0263-15 2020-07-22 ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05% 0168-0263-45 2020-07-22 ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05% 0168-0263-60 2020-07-22 ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05%
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0168-0263-15 Alclometasone Dipropionate 15 g in 1 TUBE CREAM 15 8 0168-0263-45 Alclometasone Dipropionate 45 g in 1 TUBE CREAM 45 8 0168-0263-60 Alclometasone Dipropionate 60 g in 1 TUBE CREAM 60 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALCLOMETASONE DIPROPIONATE ACTIVE INGREDIENT S56PQL4N1V ALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 ALCLOMETASONE ACTIVE MOIETY 136H45TB7B ALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 CETETH-20 INACTIVE INGREDIENT I835H2IHHX ALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S ALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 CHLOROCRESOL INACTIVE INGREDIENT 36W53O7109 ALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 ALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U ALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN ALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 POLYETHYLENE GLYCOL 4500 INACTIVE INGREDIENT TVH7653921 ALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW ALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R ALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0168-0263 ALCLOMETASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 7 Current NDC, Legacy NDC, 3 package rows 20200917_6aacce3f-aa2f-4f2c-a5bd-8cff157a3dab.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 0168-0263-15 00168026315 15 g in 1 TUBE (0168-0263-15) 15 g 2005-07-12 0000-00-00 No No Current 0168-0263-45 00168026345 45 g in 1 TUBE (0168-0263-45) 45 g 2005-07-12 0000-00-00 No No Current 0168-0263-60 00168026360 60 g in 1 TUBE (0168-0263-60) 60 g 2005-07-12 0000-00-00 No No Current