Home NDC 10337-163-60 Temovate
Product NDC 10337-163
Requested package NDC 10337-163-60
11-digit product format 103370163
Labeler code 10337
Product ID 10337-163_17dbbb71-8c20-449c-aa10-67b7d40aee18
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clobetasol propionate
Dosage form CREAM
Route TOPICAL
Labeler PharmaDerm a division of Fougera Pharmaceuticals Inc.
Application ANDA074392
Marketing category ANDA
Marketing start 1996-09-30
Marketing end 2022-06-30
Substance CLOBETASOL PROPIONATE
Active strength 1 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 A074392-001 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074392-001 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.
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 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074392-001 CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB1 1996-09-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 10337-163-30 2020-09-21 TEMOVATE ® (clobetasol propionate cream) Cream, 0.05% TEMOVATE ® (clobetasol propionate ointment) Ointment, 0.05% 10337-163-60 2020-09-21 TEMOVATE ® (clobetasol propionate cream) Cream, 0.05% TEMOVATE ® (clobetasol propionate ointment) Ointment, 0.05% 10337-163-30 2020-07-22 TEMOVATE ® (clobetasol propionate cream) Cream, 0.05% TEMOVATE ® (clobetasol propionate ointment) Ointment, 0.05% 10337-163-60 2020-07-22 TEMOVATE ® (clobetasol propionate cream) Cream, 0.05% TEMOVATE ® (clobetasol propionate ointment) Ointment, 0.05%
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded clobetasol propionate ACTIVE INGREDIENT 779619577M TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 2 clobetasol ACTIVE MOIETY ADN79D536H TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 2 cetostearyl alcohol INACTIVE INGREDIENT 2DMT128M1S TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 2 chlorocresol INACTIVE INGREDIENT 36W53O7109 TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 2 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 2 glyceryl monostearate INACTIVE INGREDIENT 230OU9XXE4 TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 2 PEG-100 stearate INACTIVE INGREDIENT YD01N1999R TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 2 petrolatum INACTIVE INGREDIENT 4T6H12BN9U TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 2 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 2 sorbitan sesquioleate INACTIVE INGREDIENT 0W8RRI5W5A TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 2 white wax INACTIVE INGREDIENT 7G1J5DA97F TEMOVATE (CLOBETASOL PROPIONATE) CREAM TEMOVATE (CLOBETASOL PROPIONATE) OINTMENT [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 2
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 10337-163-60 10337016360 1 TUBE in 1 CARTON (10337-163-60) > 60 g in 1 TUBE 1 tube 1996-09-30 0000-00-00 No No Current