Home NDC 68382-998-02 clobetasol propionate
Product NDC 68382-998
Requested package NDC 68382-998-02
11-digit product format 683820998
Labeler code 68382
Product ID 68382-998_4c2a6cc1-353f-4ed0-8a4a-a4d693d3e624
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clobetasol propionate
Dosage form SPRAY
Route TOPICAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA206378
Marketing category ANDA
Marketing start 2017-07-12
Substance CLOBETASOL PROPIONATE
Active strength .05 g/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 43 .
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 A206378-001 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206378-001 AT
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 · 43 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 2026-09-14 22:38:34 2026-08 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206378-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2017-02-16 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 .05 g/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 861512 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 68382-998-01 clobetasol propionate 1 in 1 CARTON SPRAY 1 5 68382-998-01 clobetasol propionate 59 mL in 1 BOTTLE SPRAY 59 5 68382-998-02 clobetasol propionate 125 mL in 1 BOTTLE SPRAY 125 5 68382-998-02 clobetasol propionate 1 in 1 CARTON SPRAY 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-998 CLOBETASOL PROPIONATE SPRAY [ZYDUS PHARMACEUTICALS USA INC.] 5 Current NDC, Legacy NDC, 4 package rows 20221007_8618a3bc-5601-4273-a708-27b0ecd4c385.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 68382-998-02 68382099802 1 BOTTLE in 1 CARTON (68382-998-02) / 125 mL in 1 BOTTLE 1 bottle 2017-07-12 0000-00-00 No No Current