Home NDC 51672-1350 Clobetasol Propionate
Product NDC 51672-1350
11-digit product format 516721350
Labeler code 51672
Product ID 51672-1350_3961f9ed-9667-e4ae-e063-6394a90a279f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clobetasol propionate
Dosage form LOTION
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA200302
Marketing category ANDA
Marketing start 2012-07-02
Substance CLOBETASOL PROPIONATE
Active strength .5 mg/mL
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 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 A200302-001 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200302-001 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 · 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 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200302-001 CLOBETASOL PROPIONATE 0.05% LOTION / TOPICAL AB 2012-07-02 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOBETASOL PROPIONATE .5 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861505 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 51672-1350-4 Clobetasol Propionate 1 in 1 CARTON LOTION 1 8 51672-1350-4 Clobetasol Propionate 59 mL in 1 BOTTLE LOTION 59 8 51672-1350-8 Clobetasol Propionate 1 in 1 CARTON LOTION 1 8 51672-1350-8 Clobetasol Propionate 118 mL in 1 BOTTLE LOTION 118 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded clobetasol propionate ACTIVE INGREDIENT 779619577M CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 3 Clobetasol ACTIVE MOIETY ADN79D536H CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 3 Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked) INACTIVE INGREDIENT Z135WT9208 CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 3 dimethicone INACTIVE INGREDIENT 92RU3N3Y1O CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 3 isopropyl myristate INACTIVE INGREDIENT 0RE8K4LNJS CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 3 mineral oil INACTIVE INGREDIENT T5L8T28FGP CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 3 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 3 white wax INACTIVE INGREDIENT 7G1J5DA97F CLOBETASOL PROPIONATE LOTION [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 51672-1350 CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] 7 Current NDC, Legacy NDC, 4 package rows 20241222_d4c73fb0-9675-4c41-a8bd-dd4cb2db1169.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 51672-1350-4 51672135004 1 BOTTLE in 1 CARTON (51672-1350-4) / 59 mL in 1 BOTTLE 1 bottle 2012-07-02 0000-00-00 No No Current 51672-1350-8 51672135008 1 BOTTLE in 1 CARTON (51672-1350-8) / 118 mL in 1 BOTTLE 1 bottle 2012-07-02 0000-00-00 No No Current