Home NDC 68071-2489 Clobetasol Propionate Cream USP, 0.05%
Product NDC 68071-2489
11-digit product format 680712489
Labeler code 68071
Product ID 68071-2489_c8bf92c9-1ba8-7985-e053-2995a90a0225
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clobetasol Propionate Cream USP, 0.05%
Dosage form CREAM
Route TOPICAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA212982
Marketing category ANDA
Marketing start 2020-10-01
Marketing end 0000-00-00
Substance CLOBETASOL PROPIONATE
Active strength 1 mg/g
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68071-2489-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68071-2489-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68071-2489-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68071-2489-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68071-2489-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68071-2489-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68071-2489-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68071-2489-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68071-2489-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68071-2489-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68071-2489-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68071-2489-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-2489-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-2489-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-2489-1 1332a3947898…d4bfe170f9cd…
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# FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-2489 CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% (CLOBETASOL PROPIONATE CREAM USP, 0.05%) CREAM [NUCARE PHARMACEUTICALS,INC.] 1 Legacy NDC 20210805_c8bf92c9-1ba9-7985-e053-2995a90a0225.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 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68071-2489-1 68071248901 15 g in 1 TUBE (68071-2489-1) 15 g 2021-08-04 0000-00-00 No No Current