Home NDC 21922-061 CLOBETASOL PROPIONATE
Product NDC 21922-061
11-digit product format 219220061
Labeler code 21922
Product ID 21922-061_77a7c575-4479-4611-9fb0-10744295822d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clobetasol propionate
Dosage form SOLUTION
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application ANDA076977
Marketing category ANDA
Marketing start 2024-06-10
Substance CLOBETASOL PROPIONATE
Active strength .5 mg/mL
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 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 A076977-001 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076977-001 AT
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 2005-08-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 2005-08-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 2005-08-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 2005-08-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2005-08-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 2005-08-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 2005-08-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 2005-08-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 2005-08-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 2005-08-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 2005-08-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 2005-08-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 2005-08-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 2005-08-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 2005-08-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 2005-08-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 2005-08-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076977-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL 2005-08-05 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base CLOBETASOL PROPIONATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOBETASOL PROPIONATE .5 mg/mL
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 861487 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 21922-061-22 CLOBETASOL PROPIONATE 1 in 1 CARTON SOLUTION 1 2 21922-061-22 CLOBETASOL PROPIONATE 25 mL in 1 BOTTLE SOLUTION 25 2 21922-061-27 CLOBETASOL PROPIONATE 50 mL in 1 BOTTLE SOLUTION 50 2 21922-061-27 CLOBETASOL PROPIONATE 1 in 1 CARTON SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-061 CLOBETASOL PROPIONATE SOLUTION [ENCUBE ETHICALS PRIVATE LIMITED] 1 Current NDC, 4 package rows 20240612_8ad5f9b0-b50a-4d1f-a0c1-704b5b72bf65.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 Sample Exclude flag Status 21922-061-22 21922006122 1 BOTTLE in 1 CARTON (21922-061-22) / 25 mL in 1 BOTTLE 1 bottle 2024-06-10 No No Current 21922-061-27 21922006127 1 BOTTLE in 1 CARTON (21922-061-27) / 50 mL in 1 BOTTLE 1 bottle 2024-06-10 No No Current