Home NDC 51672-1259 Clobetasol Propionate
Product NDC 51672-1259
11-digit product format 516721259
Labeler code 51672
Product ID 51672-1259_4db5c318-4c64-4e2c-e063-6294a90aa7f9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clobetasol Propionate
Dosage form OINTMENT
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA074248
Marketing category ANDA
Marketing start 1996-07-12
Substance CLOBETASOL PROPIONATE
Active strength .5 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A074248-001 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074248-001 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 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074248-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 1996-07-12 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 2027-12-31 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861434 Internal RxNorm lookup 861448 Internal RxNorm lookup 861495 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 51672-1259-1 Clobetasol Propionate 15 g in 1 TUBE OINTMENT 15 11 51672-1259-1 Clobetasol Propionate 1 in 1 CARTON OINTMENT 1 11 51672-1259-2 Clobetasol Propionate 1 in 1 CARTON OINTMENT 1 11 51672-1259-2 Clobetasol Propionate 30 g in 1 TUBE OINTMENT 30 11 51672-1259-3 Clobetasol Propionate 1 in 1 CARTON OINTMENT 1 11 51672-1259-3 Clobetasol Propionate 60 g in 1 TUBE OINTMENT 60 11 51672-1259-6 Clobetasol Propionate 45 g in 1 TUBE OINTMENT 45 11 51672-1259-6 Clobetasol Propionate 1 in 1 CARTON OINTMENT 1 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Clobetasol Propionate ACTIVE INGREDIENT 779619577M CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 Clobetasol ACTIVE MOIETY ADN79D536H CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked) INACTIVE INGREDIENT HHT01ZNK31 CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 chlorocresol INACTIVE INGREDIENT 36W53O7109 CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 glyceryl monostearate INACTIVE INGREDIENT 230OU9XXE4 CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 petrolatum INACTIVE INGREDIENT 4T6H12BN9U CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 sorbitan sesquioleate INACTIVE INGREDIENT 0W8RRI5W5A CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 water INACTIVE INGREDIENT 059QF0KO0R CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 white wax INACTIVE INGREDIENT 7G1J5DA97F CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 4 CLOBETASOL PROPIONATE ACTIVE INGREDIENT 779619577M CLOBETASOL PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 3 CLOBETASOL ACTIVE MOIETY ADN79D536H CLOBETASOL PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 3 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U CLOBETASOL PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLOBETASOL PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 3 SORBITAN SESQUIOLEATE INACTIVE INGREDIENT 0W8RRI5W5A CLOBETASOL PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1259 CLOBETASOL PROPIONATE GEL CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 8 Current NDC, Legacy NDC, 8 package rows 20230519_4a761afb-a48a-4a5a-8700-ad93601a260f.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 51672-1259-1 51672125901 1 TUBE in 1 CARTON (51672-1259-1) / 15 g in 1 TUBE 1 tube 1996-07-12 0000-00-00 No No Current 51672-1259-2 51672125902 1 TUBE in 1 CARTON (51672-1259-2) / 30 g in 1 TUBE 1 tube 1996-07-12 0000-00-00 No No Current 51672-1259-3 51672125903 1 TUBE in 1 CARTON (51672-1259-3) / 60 g in 1 TUBE 1 tube 1996-07-12 0000-00-00 No No Current 51672-1259-6 51672125906 1 TUBE in 1 CARTON (51672-1259-6) / 45 g in 1 TUBE 1 tube 1996-07-12 0000-00-00 No No Current