Home NDC 0168-0263-15 Alclometasone Dipropionate
Product NDC 0168-0263
Requested package NDC 0168-0263-15
11-digit product format 001680263
Labeler code 0168
Product ID 0168-0263_574f7b2a-667a-40fe-9728-58ef1ec8204d
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
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 2021-12-31
Current FDA listing Historical FDA.report record 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 Legacy NDC, 3 package rows 20200917_6aacce3f-aa2f-4f2c-a5bd-8cff157a3dab.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 0168-0263-15 00168026315 15 g in 1 TUBE (0168-0263-15) 15 g 2005-07-12 0000-00-00 No No Current