Home NDC 68462-608 Clobetasol Propionate
Product NDC 68462-608
11-digit product format 684620608
Labeler code 68462
Product ID 68462-608_f995c5e9-6e42-423f-b475-ec0347aeca97
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clobetasol propionate
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA210809
Marketing category ANDA
Marketing start 2019-02-16
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 A210809-001 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210809-001 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 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210809-001 CLOBETASOL PROPIONATE 0.05% AEROSOL, FOAM / TOPICAL AB1 2019-02-15 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861353 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 68462-608-27 Clobetasol Propionate 50 g in 1 CAN AEROSOL, FOAM 50 9 68462-608-94 Clobetasol Propionate 100 g in 1 CAN AEROSOL, FOAM 100 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-608 CLOBETASOL PROPIONATE AEROSOL, FOAM [GLENMARK PHARMACEUTICALS INC., USA] 8 Current NDC, Legacy NDC, 2 package rows 20230706_db8c7a36-e950-44b9-b2ff-7fede2e87407.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 68462-608-27 68462060827 50 g in 1 CAN (68462-608-27) 50 g 2019-02-16 0000-00-00 No No Current 68462-608-94 68462060894 100 g in 1 CAN (68462-608-94) 100 g 2019-02-16 0000-00-00 No No Current