Home NDC 0781-7137-04 clobetasol propionate
Product NDC 0781-7137
Requested package NDC 0781-7137-04
11-digit product format 007817137
Labeler code 0781
Product ID 0781-7137_dc343075-10a8-439d-9eb2-a2e760b402a9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clobetasol propionate
Dosage form SHAMPOO
Route TOPICAL
Labeler Sandoz Inc.
Application NDA021644
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2011-12-22
Marketing end 2022-04-30
Substance CLOBETASOL PROPIONATE
Active strength 0 g/100mL
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 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 N021644-001 CLOBEX CLOBETASOL PROPIONATE 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021644-001 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 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021644-001 CLOBEX 0.05% SHAMPOO / TOPICAL AB RLD, RS 2004-02-05 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# DailyMed Socrata Ingredients# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0781-7137-04 00781713704 1 BOTTLE in 1 CARTON (0781-7137-04) > 118 mL in 1 BOTTLE 1 bottle 2012-01-04 2022-04-30 No No Current