Home NDC 21922-072 MOMETASONE FUROATE
Product NDC 21922-072
11-digit product format 219220072
Labeler code 21922
Product ID 21922-072_c336602d-2291-4ab2-97b2-8390f2f5270d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MOMETASONE FUROATE
Dosage form LOTION
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application ANDA076499
Marketing category ANDA
Marketing start 2025-01-22
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 A076499-001 MOMETASONE FUROATE MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2007-11-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076499-001 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 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2007-11-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2007-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2007-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2007-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2007-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2007-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2007-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2007-11-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2007-11-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2007-11-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2007-11-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL AB 2007-11-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076499-001 MOMETASONE FUROATE 0.1% LOTION / TOPICAL 2007-11-21 e64feba35796…
Observed Orange Book normalized TE history# 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 21922-072-01 MOMETASONE FUROATE 60 mL in 1 BOTTLE LOTION 60 2 21922-072-01 MOMETASONE FUROATE 1 in 1 BOTTLE LOTION 1 2 21922-072-21 MOMETASONE FUROATE 30 mL in 1 BOTTLE LOTION 30 2 21922-072-21 MOMETASONE FUROATE 1 in 1 CARTON LOTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-072 MOMETASONE FUROATE LOTION [ENCUBE ETHICALS PRIVATE LIMITED] 1 Current NDC, 4 package rows 20250123_1ebaac16-432e-4e92-9d58-718bd76ae368.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 Units Marketing start Sample Exclude flag Status 21922-072-01 21922007201 1 BOTTLE in 1 BOTTLE (21922-072-01) / 60 mL in 1 BOTTLE 1 bottle 2025-01-22 No No Current 21922-072-21 21922007221 1 BOTTLE in 1 CARTON (21922-072-21) / 30 mL in 1 BOTTLE 1 bottle 2025-01-22 No No Current