Home NDC 33342-506 Clobetasol Propionate
Product NDC 33342-506
11-digit product format 333420506
Labeler code 33342
Product ID 33342-506_92cf4231-e301-4353-98d9-85206ec6ba96
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clobetasol Propionate
Dosage form OINTMENT
Route TOPICAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA215990
Marketing category ANDA
Marketing start 2023-12-28
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 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 A215990-001 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2023-12-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215990-001 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.
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 A215990-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2023-12-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215990-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2023-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215990-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2023-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215990-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2023-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215990-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2023-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215990-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2023-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215990-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2023-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215990-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2023-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215990-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2023-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215990-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2023-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215990-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2023-12-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215990-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2023-12-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215990-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2023-12-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215990-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2023-12-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215990-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2023-12-28 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215990-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2023-12-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215990-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2023-12-28 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215990-001 CLOBETASOL PROPIONATE 0.05% OINTMENT / TOPICAL AB 2023-12-28 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Clobetasol Propionate
Brand name suffix ANDA
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 33342-506-15 Clobetasol PropionateANDA 15 g in 1 TUBE OINTMENT 15 1 33342-506-15 Clobetasol PropionateANDA 1 in 1 CARTON OINTMENT 1 1 33342-506-30 Clobetasol PropionateANDA 1 in 1 CARTON OINTMENT 1 1 33342-506-30 Clobetasol PropionateANDA 30 g in 1 TUBE OINTMENT 30 1 33342-506-45 Clobetasol PropionateANDA 1 in 1 CARTON OINTMENT 1 1 33342-506-45 Clobetasol PropionateANDA 45 g in 1 TUBE OINTMENT 45 1 33342-506-60 Clobetasol PropionateANDA 60 g in 1 TUBE OINTMENT 60 1 33342-506-60 Clobetasol PropionateANDA 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 33342-506 CLOBETASOL PROPIONATE ANDA (CLOBETASOL PROPIONATE) OINTMENT [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 8 package rows 20240113_92cf4231-e301-4353-98d9-85206ec6ba96.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 33342-506-15 33342050615 1 TUBE in 1 CARTON (33342-506-15) / 15 g in 1 TUBE 1 tube 2023-12-28 No No Current 33342-506-30 33342050630 1 TUBE in 1 CARTON (33342-506-30) / 30 g in 1 TUBE 1 tube 2023-12-28 No No Current 33342-506-45 33342050645 1 TUBE in 1 CARTON (33342-506-45) / 45 g in 1 TUBE 1 tube 2023-12-28 No No Current 33342-506-60 33342050660 1 TUBE in 1 CARTON (33342-506-60) / 60 g in 1 TUBE 1 tube 2023-12-28 No No Current