Home NDC 43386-096 clobetasol propionate
Product NDC 43386-096
11-digit product format 433860096
Labeler code 43386
Product ID 43386-096_370129be-84f5-4edf-b821-ffbad2db8c66
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clobetasol propionate
Dosage form OINTMENT
Route TOPICAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA208841
Marketing category ANDA
Marketing start 2018-06-02
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 A208841-001 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208841-001 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 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208841-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2018-05-04 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 861448 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 43386-096-60 clobetasol propionate 15 g in 1 TUBE OINTMENT 15 1 43386-096-60 clobetasol propionate 1 in 1 CARTON OINTMENT 1 1 43386-096-61 clobetasol propionate 1 in 1 CARTON OINTMENT 1 1 43386-096-61 clobetasol propionate 30 g in 1 TUBE OINTMENT 30 1 43386-096-62 clobetasol propionate 60 g in 1 TUBE OINTMENT 60 1 43386-096-62 clobetasol propionate 1 in 1 CARTON OINTMENT 1 1 43386-096-63 clobetasol propionate 45 g in 1 TUBE OINTMENT 45 1 43386-096-63 clobetasol propionate 1 in 1 CARTON OINTMENT 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-096 CLOBETASOL PROPIONATE OINTMENT [LUPIN PHARMACEUTICALS,INC.] 1 Current NDC, Legacy NDC, 8 package rows 20180814_3e0fe7b1-f511-491f-b74d-3ca00449835b.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 · 2 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 43386-096-60 43386009660 1 TUBE in 1 CARTON (43386-096-60) / 15 g in 1 TUBE 1 tube 2018-06-02 0000-00-00 No No Current 43386-096-61 43386009661 1 TUBE in 1 CARTON (43386-096-61) / 30 g in 1 TUBE 1 tube 2018-06-02 0000-00-00 No No Current 43386-096-62 43386009662 1 TUBE in 1 CARTON (43386-096-62) / 60 g in 1 TUBE 1 tube 2018-06-02 0000-00-00 No No Current 43386-096-63 43386009663 1 TUBE in 1 CARTON (43386-096-63) / 45 g in 1 TUBE 1 tube 2018-06-02 0000-00-00 No No Current