Home NDC 45802-118 Mometasone Furoate
Product NDC 45802-118
11-digit product format 458020118
Labeler code 45802
Product ID 45802-118_fe1488ac-a59e-4396-846f-d97b41ae7924
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mometasone Furoate
Dosage form SOLUTION
Route TOPICAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application ANDA077180
Marketing category ANDA
Marketing start 2008-12-11
Substance MOMETASONE FUROATE
Active strength 1 mg/mL
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 A077180-001 MOMETASONE FUROATE MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077180-001 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 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2005-04-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2005-04-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2005-04-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2005-04-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2005-04-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2005-04-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2005-04-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2005-04-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2005-04-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2005-04-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2005-04-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2005-04-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2005-04-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB RS 2005-04-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2005-04-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2005-04-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2005-04-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077180-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2005-04-06 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 1 mg/mL
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 151030 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 45802-118-46 Mometasone Furoate 1 in 1 CARTON SOLUTION 1 7 45802-118-46 Mometasone Furoate 60 mL in 1 BOTTLE SOLUTION 60 7 45802-118-59 Mometasone Furoate 30 mL in 1 BOTTLE SOLUTION 30 7 45802-118-59 Mometasone Furoate 1 in 1 CARTON SOLUTION 1 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-118 MOMETASONE FUROATE SOLUTION [PADAGIS ISRAEL PHARMACEUTICALS LTD] 7 Current NDC, Legacy NDC, 4 package rows 20230425_7296b4a2-f180-4887-a8e0-029f81aec566.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 45802-118-46 45802011846 1 BOTTLE in 1 CARTON (45802-118-46) / 60 mL in 1 BOTTLE 1 bottle 2008-12-11 0000-00-00 No No Current 45802-118-59 45802011859 1 BOTTLE in 1 CARTON (45802-118-59) / 30 mL in 1 BOTTLE 1 bottle 2009-02-02 0000-00-00 No No Current