Home NDC 68788-4075-4 Mometasone Furoate
Product NDC 68788-4075
Requested package NDC 68788-4075-4
11-digit product format 687884075
Labeler code 68788
Product ID 68788-4075_ad47cceb-e471-48d6-85d6-e4a3f10e2ac6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mometasone Furoate
Dosage form CREAM
Route TOPICAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA077447
Marketing category ANDA
Marketing start 2026-01-27
Substance MOMETASONE FUROATE
Active strength 1 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], 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 A077447-001 MOMETASONE FUROATE MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2006-05-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077447-001 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 2026-08-01 22:54:32 2026-06 A077447-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2006-05-22 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A077447-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Mometasone Furoate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MOMETASONE FUROATE 1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04201GDN4R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311753 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 68788-4075-4 Mometasone Furoate 45 g in 1 TUBE CREAM 45 1 68788-4075-4 Mometasone Furoate 1 in 1 CARTON CREAM 1 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68788-4075-4 68788407504 1 TUBE in 1 CARTON (68788-4075-4) / 45 g in 1 TUBE 1 tube 2026-01-27 No No Current