Home NDC 50383-267-45 Clobetasol Propionate
Product NDC 50383-267
Requested package NDC 50383-267-45
11-digit product format 503830267
Labeler code 50383
Product ID 50383-267_e5680f3e-ab53-4716-a708-3e12e118a867
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clobetasol Propionate
Dosage form CREAM
Route TOPICAL
Labeler Akorn
Application ANDA074220
Marketing category ANDA
Marketing start 2010-06-07
Marketing end 0000-00-00
Substance CLOBETASOL PROPIONATE
Active strength 1 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A074220-001 CORMAX CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 1997-05-16
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 · 43 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 2026-09-14 22:38:34 2026-08 A074220-001 CORMAX 0.05% CREAM / TOPICAL 1997-05-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074220-001 CORMAX 0.05% CREAM / TOPICAL 1997-05-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074220-001 CORMAX 0.05% CREAM / TOPICAL 1997-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074220-001 CORMAX 0.05% CREAM / TOPICAL 1997-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074220-001 CORMAX 0.05% CREAM / TOPICAL 1997-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074220-001 CORMAX 0.05% CREAM / TOPICAL 1997-05-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074220-001 CORMAX 0.05% CREAM / TOPICAL 1997-05-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074220-001 CORMAX 0.05% CREAM / TOPICAL 1997-05-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074220-001 CORMAX 0.05% CREAM / TOPICAL 1997-05-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074220-001 CORMAX 0.05% CREAM / TOPICAL 1997-05-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074220-001 CORMAX 0.05% CREAM / TOPICAL 1997-05-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074220-001 CORMAX 0.05% CREAM / TOPICAL 1997-05-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074220-001 CORMAX 0.05% CREAM / TOPICAL 1997-05-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074220-001 CORMAX 0.05% CREAM / TOPICAL 1997-05-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074220-001 CORMAX 0.05% CREAM / TOPICAL 1997-05-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074220-001 CORMAX 0.05% CREAM / TOPICAL 1997-05-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 RS 1997-05-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 RS 1997-05-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 RS 1997-05-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 RS 1997-05-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 RS 1997-05-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 RS 1997-05-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 RS 1997-05-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 RS 1997-05-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 RS 1997-05-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 RS 1997-05-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 RS 1997-05-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 RS 1997-05-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 RS 1997-05-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 1997-05-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 1997-05-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 1997-05-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 1997-05-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 1997-05-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 1997-05-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 RS 1997-05-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 RS 1997-05-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 RS 1997-05-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 RS 1997-05-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074220-001 CORMAX 0.05% CREAM / TOPICAL AB1 RS 1997-05-16 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 50383-267-15 Clobetasol Propionate Cream, USP, 0.05% Clobetasol Propionate Ointment, USP, 0.05% 50383-267-30 Clobetasol Propionate Cream, USP, 0.05% Clobetasol Propionate Ointment, USP, 0.05% 50383-267-45 Clobetasol Propionate Cream, USP, 0.05% Clobetasol Propionate Ointment, USP, 0.05% 50383-267-60 Clobetasol Propionate Cream, USP, 0.05% Clobetasol Propionate Ointment, USP, 0.05%
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLOBETASOL PROPIONATE ACTIVE INGREDIENT 779619577M CLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 3 CLOBETASOL ACTIVE MOIETY ADN79D536H CLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 3 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN CLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 3 GLYCOL STEARATE INACTIVE INGREDIENT 0324G66D0E CLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 3 LANOLIN INACTIVE INGREDIENT 7EV65EAW6H CLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 3 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 3 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U CLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 3 POLYOXYL 8 STEARATE INACTIVE INGREDIENT 2P9L47VI5E CLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 3 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M CLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 3 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 3 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 3 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 3 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y CLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R CLOBETASOL PROPIONATE CREAM [PHYSICIANS TOTAL CARE, INC.] 3 CLOBETASOL PROPIONATE ACTIVE INGREDIENT 779619577M CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 CLOBETASOL ACTIVE MOIETY ADN79D536H CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 GLYCOL STEARATE INACTIVE INGREDIENT 0324G66D0E CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 LANOLIN INACTIVE INGREDIENT 7EV65EAW6H CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 PEG-8 STEARATE INACTIVE INGREDIENT 2P9L47VI5E CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 SORBITAN SESQUIOLEATE INACTIVE INGREDIENT 0W8RRI5W5A CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [HI-TECH PHARMACAL CO., INC.] 2 CLOBETASOL PROPIONATE ACTIVE INGREDIENT 779619577M CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 CLOBETASOL ACTIVE MOIETY ADN79D536H CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 GLYCOL STEARATE INACTIVE INGREDIENT 0324G66D0E CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 LANOLIN INACTIVE INGREDIENT 7EV65EAW6H CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 PEG-8 STEARATE INACTIVE INGREDIENT 2P9L47VI5E CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 SORBITAN SESQUIOLEATE INACTIVE INGREDIENT 0W8RRI5W5A CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50383-267 CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [AKORN] 6 Legacy NDC 20221202_fb29b17b-96af-4a78-bc91-83cf8c5c2b1d.zip
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 50383-267-45 50383026745 1 TUBE in 1 CARTON (50383-267-45) > 45 g in 1 TUBE 1 tube 2010-06-07 0000-00-00 No No Current