Home NDC 82804-083 Clobetasol Propionate
Product NDC 82804-083
11-digit product format 828040083
Labeler code 82804
Product ID 82804-083_e0f7bc85-9c13-44df-9b37-c216ecfe3ffe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clobetasol propionate
Dosage form CREAM
Route TOPICAL
Labeler Proficient Rx LP
Application ANDA074392
Marketing category ANDA
Marketing start 1996-09-30
Substance CLOBETASOL PROPIONATE
Active strength .5 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A074392-001 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074392-001 AB1
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 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 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.
Additional Listing Data#
Finished product Yes
Brand name base Clobetasol Propionate
Listing expiration 2027-12-31 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 861495 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 82804-083-30 Clobetasol Propionate 30 g in 1 TUBE CREAM 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82804-083 CLOBETASOL PROPIONATE CREAM [PROFICIENT RX LP] 1 Current NDC, 1 package rows 20240407_e0f7bc85-9c13-44df-9b37-c216ecfe3ffe.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82804-083-30 82804008330 30 g in 1 TUBE (82804-083-30) 30 g 2024-03-28 No No Current