Home NDC 33342-326 Clobetasol Propionate
Product NDC 33342-326
11-digit product format 333420326
Labeler code 33342
Product ID 33342-326_44ced6ce-fa10-426d-a498-a13b8b34f49a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clobetasol Propionate
Dosage form SPRAY
Route TOPICAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA214345
Marketing category ANDA
Marketing start 2024-12-03
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 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 A214345-001 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL 2024-12-02
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 2026-02-19 14:30 UTC 2026-02 A214345-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL 2024-12-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214345-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL 2024-12-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214345-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL 2024-12-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214345-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2024-12-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214345-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2024-12-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214345-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2024-12-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214345-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL AT 2024-12-02 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214345-001 CLOBETASOL PROPIONATE 0.05% SPRAY / TOPICAL 2024-12-02 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214345-001 AT 1 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214345-001 AT 1 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214345-001 AT 1 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214345-001 AT 1 2680178bc6a6…
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 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 33342-326-87 Clobetasol Propionate 1 in 1 CARTON SPRAY 1 1 33342-326-87 Clobetasol Propionate 59 mL in 1 BOTTLE, PUMP SPRAY 59 1 33342-326-88 Clobetasol Propionate 1 in 1 CARTON SPRAY 1 1 33342-326-88 Clobetasol Propionate 125 mL in 1 BOTTLE, PUMP SPRAY 125 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-326 CLOBETASOL PROPIONATE SPRAY [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 4 package rows 20250212_44ced6ce-fa10-426d-a498-a13b8b34f49a.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 Marketing start Sample Exclude flag Status 33342-326-87 33342032687 1 BOTTLE, PUMP in 1 CARTON (33342-326-87) / 59 mL in 1 BOTTLE, PUMP 2024-12-03 No No Current 33342-326-88 33342032688 1 BOTTLE, PUMP in 1 CARTON (33342-326-88) / 125 mL in 1 BOTTLE, PUMP 2024-12-03 No No Current