Home NDC 50090-5778-0 Clobetasol Propionate
Product NDC 50090-5778
Requested package NDC 50090-5778-0
11-digit product format 500905778
Labeler code 50090
Product ID 50090-5778_8ce776be-6cca-461a-9a85-9523f809abe1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clobetasol Propionate
Dosage form SOLUTION
Route TOPICAL
Labeler A-S Medication Solutions
Application ANDA209361
Marketing category ANDA
Marketing start 2017-11-04
Marketing end 0000-00-00
Substance CLOBETASOL PROPIONATE
Active strength 0 mg/mL
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-5778 50090-5778-0 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-5778 50090-5778-0 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A209361-001 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209361-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209361-001 CLOBETASOL PROPIONATE 0.05% SOLUTION / TOPICAL AT 2017-10-25 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Clobetasol Propionate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOBETASOL PROPIONATE .4625 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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 50090-5778-0 2023-02-07 C162847 48780-1 f386c64a-29e8-0266-e053-dadaa90a7c1a Clobetasol Propionate Topical Solution, USP, 0.05% w/w Rx Only FOR TOPICAL DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. 50090-5778-0 2023-01-30 C162847 48780-1 f386c64a-29e8-0266-e053-dadaa90a7c1a Clobetasol Propionate Topical Solution, USP, 0.05% w/w Rx Only FOR TOPICAL DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.
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 · 2 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 50090-5778-0 50090577800 1 BOTTLE in 1 CARTON (50090-5778-0) > 50 mL in 1 BOTTLE 1 bottle 2021-10-07 0000-00-00 No No Current