Home NDC 65162-891 Mometasone Furoate
Product NDC 65162-891
11-digit product format 651620891
Labeler code 65162
Product ID 65162-891_d6a5b296-7bb8-4a4c-b9f1-2f7fe70a50cf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mometasone
Dosage form SPRAY, METERED
Route NASAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA207989
Marketing category ANDA
Marketing start 2017-04-04
Substance MOMETASONE FUROATE
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 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 A207989-001 MOMETASONE FUROATE MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207989-001 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.
Product history page 1 of 2 · 42 observed 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 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207989-001 MOMETASONE FUROATE EQ 0.05MG BASE/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207989-001 MOMETASONE FUROATE EQ 0.05MG BASE/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207989-001 MOMETASONE FUROATE EQ 0.05MG BASE/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207989-001 MOMETASONE FUROATE EQ 0.05MG BASE/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207989-001 MOMETASONE FUROATE 0.05MG/SPRAY SPRAY, METERED / NASAL AB 2017-04-03 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 50 ug/1
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 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 65162-891-29 Mometasone Furoate 120 in 1 BOTTLE, PUMP SPRAY, METERED 120 13 65162-891-29 Mometasone Furoate 1 in 1 CARTON SPRAY, METERED 1 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-891 MOMETASONE FUROATE (MOMETASONE) SPRAY, METERED [AMNEAL PHARMACEUTICALS LLC] 13 Current NDC, Legacy NDC, 2 package rows 20240117_ff41e901-5a6f-4ad5-be8a-a68eae787e5e.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 Marketing end Sample Exclude flag Status 65162-891-29 65162089129 1 BOTTLE, PUMP in 1 CARTON (65162-891-29) / 120 SPRAY, METERED in 1 BOTTLE, PUMP 2017-04-04 0000-00-00 No No Current