Home NDC 51672-1297-1 Clobetasol Propionate
Product NDC 51672-1297
Requested package NDC 51672-1297-1
11-digit product format 516721297
Labeler code 51672
Product ID 51672-1297_3cf4526e-e856-d065-e063-6394a90a12bc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clobetasol Propionate
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA075633
Marketing category ANDA
Marketing start 2000-05-17
Substance CLOBETASOL PROPIONATE
Active strength .5 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL AB2 2000-05-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075633-001 AB2
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 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075633-001 CLOBETASOL PROPIONATE (EMOLLIENT) 0.05% CREAM / TOPICAL AB2 2000-05-17 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 .5 mg/g
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 1992281 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 51672-1297-1 Clobetasol Propionate 1 in 1 CARTON CREAM 1 8 51672-1297-1 Clobetasol Propionate 15 g in 1 TUBE CREAM 15 8 51672-1297-2 Clobetasol Propionate 30 g in 1 TUBE CREAM 30 8 51672-1297-2 Clobetasol Propionate 1 in 1 CARTON CREAM 1 8 51672-1297-3 Clobetasol Propionate 1 in 1 CARTON CREAM 1 8 51672-1297-3 Clobetasol Propionate 60 g in 1 TUBE CREAM 60 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Clobetasol Propionate ACTIVE INGREDIENT 779619577M CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 Clobetasol ACTIVE MOIETY ADN79D536H CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 ceteth-20 INACTIVE INGREDIENT I835H2IHHX CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 cetostearyl alcohol INACTIVE INGREDIENT 2DMT128M1S CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 dimethicone 350 INACTIVE INGREDIENT 2Y53S6ATLU CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 imidurea INACTIVE INGREDIENT M629807ATL CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 isopropyl myristate INACTIVE INGREDIENT 0RE8K4LNJS CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R CLOBETASOL PROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1297 CLOBETASOL PROPIONATE CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.] 7 Current NDC, Legacy NDC, 6 package rows 20250524_91571297-03ad-441e-8ec6-f78c21fbe5e8.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 51672-1297-1 51672129701 1 TUBE in 1 CARTON (51672-1297-1) / 15 g in 1 TUBE 1 tube 2000-05-17 0000-00-00 No No Current