Home NDC 0472-0404 Clobetasol Propionate
Product NDC 0472-0404
11-digit product format 004720404
Labeler code 0472
Product ID 0472-0404_7dc00a2f-fcdd-46e8-b0f1-c2a050f81e8a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clobetasol Propionate
Dosage form LOTION
Route TOPICAL
Labeler Actavis Pharma, Inc.
Application ANDA078223
Marketing category ANDA
Marketing start 2012-01-02
Substance CLOBETASOL PROPIONATE
Active strength .05 g/100mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A078223-001 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078223-001 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 · 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 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078223-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2008-12-04 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 .05 g/100mL
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 861505 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 0472-0404-91 Clobetasol Propionate 30 mL in 1 BOTTLE LOTION 30 7 0472-0404-91 Clobetasol Propionate 1 in 1 CARTON LOTION 1 7 0472-0404-92 Clobetasol Propionate 59 mL in 1 BOTTLE LOTION 59 7 0472-0404-92 Clobetasol Propionate 1 in 1 CARTON LOTION 1 7 0472-0404-94 Clobetasol Propionate 1 in 1 CARTON LOTION 1 7 0472-0404-94 Clobetasol Propionate 118 mL in 1 BOTTLE LOTION 118 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0472-0404 CLOBETASOL PROPIONATE LOTION [ACTAVIS PHARMA, INC.] 7 Current NDC, Legacy NDC, 6 package rows 20200414_afd20e23-b7a6-46ca-bd8d-b7af9ff84201.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 Marketing end Sample Exclude flag Status 0472-0404-91 00472040491 30 mL in 1 BOTTLE 30 ml Historical 0472-0404-92 00472040492 1 BOTTLE in 1 CARTON (0472-0404-92) / 59 mL in 1 BOTTLE 1 bottle 2012-01-02 0000-00-00 No No Current 0472-0404-94 00472040494 1 BOTTLE in 1 CARTON (0472-0404-94) / 118 mL in 1 BOTTLE 1 bottle 2012-01-02 0000-00-00 No No Current