Home NDC 59651-402 MOMETASONE FUROATE MONOHYDRATE
Product NDC 59651-402
11-digit product format 596510402
Labeler code 59651
Product ID 59651-402_b24f80c5-afe2-4821-9185-2dad3cfe277a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MOMETASONE FUROATE MONOHYDRATE
Dosage form SPRAY, METERED
Route NASAL
Labeler Aurobindo Pharma Limited
Application ANDA215878
Marketing category ANDA
Marketing start 2024-03-18
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 A215878-001 MOMETASONE FUROATE MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2024-03-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215878-001 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 2026-02-19 14:30 UTC 2026-02 A215878-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2024-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215878-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2024-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215878-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2024-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215878-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2024-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215878-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2024-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215878-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2024-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215878-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2024-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215878-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2024-03-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215878-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2024-03-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215878-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2024-03-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215878-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2024-03-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215878-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2024-03-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215878-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2024-03-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215878-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2024-03-18 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215878-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2024-03-18 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base MOMETASONE FUROATE MONOHYDRATE
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 59651-402-17 MOMETASONE FUROATE MONOHYDRATE 1 in 1 CARTON SPRAY, METERED 1 1 59651-402-17 MOMETASONE FUROATE MONOHYDRATE 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 59651-402 MOMETASONE FUROATE MONOHYDRATE SPRAY, METERED [AUROBINDO PHARMA LIMITED] 1 Current NDC, 2 package rows 20240326_b24f80c5-afe2-4821-9185-2dad3cfe277a.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 59651-402-17 59651040217 1 BOTTLE, SPRAY in 1 CARTON (59651-402-17) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY 2024-03-18 No No Current