Home NDC 21922-016 Clobetasol Propionate Cream USP, 0.05%
Product NDC 21922-016
11-digit product format 219220016
Labeler code 21922
Product ID 21922-016_03d5cd0f-1991-440f-9942-6a140f762b6b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clobetasol Propionate Cream USP, 0.05%
Dosage form CREAM
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application ANDA212982
Marketing category ANDA
Marketing start 2020-10-01
Substance CLOBETASOL PROPIONATE
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 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 A212982-001 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212982-001 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.
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 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2020-08-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2020-08-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2020-08-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2020-08-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2020-08-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2020-08-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2020-08-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2020-08-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2020-08-28 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2020-08-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2020-08-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2020-08-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2020-08-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2020-08-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2020-08-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 2020-08-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212982-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 RS 2020-08-28 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Clobetasol Propionate Cream USP, 0.05%
Brand name suffix Clobetasol Propionate Cream USP, 0.05%
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 21922-016-04 Clobetasol Propionate Cream USP, 0.05%Clobetasol Propionate Cream USP, 0.05% 15 g in 1 TUBE CREAM 15 4 21922-016-05 Clobetasol Propionate Cream USP, 0.05%Clobetasol Propionate Cream USP, 0.05% 30 g in 1 TUBE CREAM 30 4 21922-016-06 Clobetasol Propionate Cream USP, 0.05%Clobetasol Propionate Cream USP, 0.05% 45 g in 1 TUBE CREAM 45 4 21922-016-07 Clobetasol Propionate Cream USP, 0.05%Clobetasol Propionate Cream USP, 0.05% 60 g in 1 TUBE CREAM 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-016 CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% (CLOBETASOL PROPIONATE CREAM USP, 0.05%) CREAM [ENCUBE ETHICALS PRIVATE LIMITED] 3 Current NDC, Legacy NDC, 4 package rows 20241017_bcb76b4b-194d-4cb3-b3ed-26b911df1a11.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 · 10 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% Encube Ethicals, Inc. bcb76b4b-194d-4cb3-b3ed-26b911df1a11 2026-07-09 Adverse reactions Exact identifier application applno (ANDA): 212982 application number: ANDA212982 ndc (product): 21922-016 Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% CLOBETASOL PROPIONATE USP, 0.05% A-S Medication Solutions d40ea303-9eba-4750-955d-6bb005882fb5 2026-01-06 Adverse reactions Exact identifier application applno (ANDA): 212982 application number: ANDA212982 Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% CLOBETASOL PROPIONATE USP, 0.05% A-S Medication Solutions 98b23b99-fab4-49fb-b070-758fb030e9bb 2025-12-04 Adverse reactions Exact identifier application applno (ANDA): 212982 application number: ANDA212982 Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% Bryant Ranch Prepack e9af15cc-7795-44e8-b294-057630981824 2025-10-22 Adverse reactions Exact identifier application applno (ANDA): 212982 application number: ANDA212982 Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% REMEDYREPACK INC. 61f63eec-ecf3-4979-adab-f26eb8f29d65 2025-10-02 Adverse reactions Exact identifier application applno (ANDA): 212982 application number: ANDA212982 Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% Bryant Ranch Prepack 29113d5e-1570-4fc5-9ce6-a00230e4377e 2025-09-16 Adverse reactions Exact identifier application applno (ANDA): 212982 application number: ANDA212982 Clobetasol Propionate Cream 0.05% Clobetasol Propionate Cream 0.05% CLOBETASOL PROPIONATE CREAM 0.05% Preferred Pharmaceuticals Inc. 1917a2a1-1591-4383-8466-ae12988b209f 2025-08-01 Adverse reactions Exact identifier application applno (ANDA): 212982 application number: ANDA212982 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE DIRECT RX cc716dab-b535-8b51-e053-2995a90a8f16 2025-01-20 Adverse reactions Exact identifier application applno (ANDA): 212982 application number: ANDA212982 Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% Northstar Rx LLC 2a356447-46d2-40cc-b850-f387982c517a 2024-09-09 Adverse reactions Exact identifier application applno (ANDA): 212982 application number: ANDA212982 Clobetasol Propionate Cream, 0.05% Clobetasol Propionate Cream, 0.05% CLOBETASOL PROPIONATE CREAM, 0.05% Proficient Rx LP 6f52ac0f-4028-4733-9ef6-e5ce5468b384 2024-08-01 Adverse reactions Exact identifier application applno (ANDA): 212982 application number: ANDA212982
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 21922-016-04 21922001604 15 g in 1 TUBE (21922-016-04) 15 g 2020-10-01 0000-00-00 No No Current 21922-016-05 21922001605 30 g in 1 TUBE (21922-016-05) 30 g 2020-10-01 0000-00-00 No No Current 21922-016-06 21922001606 45 g in 1 TUBE (21922-016-06) 45 g 2020-10-01 0000-00-00 No No Current 21922-016-07 21922001607 60 g in 1 TUBE (21922-016-07) 60 g 2020-10-01 0000-00-00 No No Current