Home NDC 58602-522 MOMETASONE FUROATE
Product NDC 58602-522
11-digit product format 586020522
Labeler code 58602
Product ID 58602-522_48ba8c52-73b6-4ee9-ba13-756a645a9183
Type HUMAN OTC DRUG
Nonproprietary name MOMETASONE FUROATE
Dosage form SPRAY, METERED
Route NASAL
Labeler Aurohealth LLC
Application ANDA217498
Marketing category ANDA
Marketing start 2024-11-22
Substance MOMETASONE FUROATE MONOHYDRATE
Active strength 50 ug/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], 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 A217498-001 MOMETASONE FUROATE MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2024-11-22
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 A217498-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2024-11-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217498-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2024-11-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217498-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2024-11-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217498-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2024-11-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217498-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2024-11-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217498-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2024-11-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217498-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2024-11-22 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217498-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL 2024-11-22 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base MOMETASONE FUROATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MOMETASONE FUROATE MONOHYDRATE 50 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MTW0WEG809 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1797865 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 58602-522-44 MOMETASONE FUROATE 1 in 1 CARTON SPRAY, METERED 1 1 58602-522-44 MOMETASONE FUROATE 120 in 1 BOTTLE, SPRAY SPRAY, METERED 120 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58602-522 MOMETASONE FUROATE SPRAY, METERED [AUROHEALTH LLC] 1 Current NDC, 2 package rows 20241204_48ba8c52-73b6-4ee9-ba13-756a645a9183.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 58602-522-44 58602052244 1 BOTTLE, SPRAY in 1 CARTON (58602-522-44) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY 2024-11-22 No No Current