Home NDC 68258-3997 Mometasone Furoate
Product NDC 68258-3997
11-digit product format 682583997
Labeler code 68258
Product ID 68258-3997_66802b4e-32f9-42a2-bb4a-b6aa7734b1e3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mometasone Furoate
Dosage form OINTMENT
Route TOPICAL
Labeler Dispensing Solutions, Inc.
Application ANDA077401
Marketing category ANDA
Marketing start 2006-10-18
Marketing end 0000-00-00
Substance MOMETASONE FUROATE
Active strength 1 mg/g
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68258-3997-4 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68258-3997-4 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68258-3997-4 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68258-3997-4 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68258-3997-4 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68258-3997-4 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68258-3997-4 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68258-3997-4 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68258-3997-4 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68258-3997-4 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68258-3997-4 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68258-3997-4 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68258-3997-4 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68258-3997-4 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68258-3997-4 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 68258-3997-4 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 68258-3997-4 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 68258-3997-4 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 68258-3997-4 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 68258-3997-4 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 68258-3997-4 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 68258-3997-4 110d247fa046…a55b01930146…
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 A077401-001 MOMETASONE FUROATE MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077401-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68258-3997-4 Mometasone Furoate 45 g in 1 TUBE OINTMENT 45 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Mometasone Furoate ACTIVE INGREDIENT 04201GDN4R MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1 Mometasone Furoate ACTIVE MOIETY 04201GDN4R MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1 Hexylene Glycol INACTIVE INGREDIENT KEH0A3F75J MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1 Phosphoric Acid INACTIVE INGREDIENT E4GA8884NN MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1 Propylene Glycol Monopalmitostearate INACTIVE INGREDIENT F76354LMGR MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1 Stearyl Alcohol INACTIVE INGREDIENT 2KR89I4H1Y MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1 White Wax INACTIVE INGREDIENT 7G1J5DA97F MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68258-3997 MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1 Legacy NDC, 1 package rows 20120313_db303d11-eba4-49f7-bf9c-7d944ddb43e7.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 Status 68258-3997-4 68258399704 45 g in 1 TUBE 45 g Historical