Home NDC 13668-527 Mometasone Furoate
Product NDC 13668-527
11-digit product format 136680527
Labeler code 13668
Product ID 13668-527_4ea0ace8-3f86-42c2-9242-7eef56d15174
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mometasone Furoate
Dosage form OINTMENT
Route TOPICAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA207899
Marketing category ANDA
Marketing start 2024-12-15
Substance MOMETASONE FUROATE
Active strength 1 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 9 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 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 13668-527-04 ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 13668-527-01 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 13668-527-04 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 13668-527-01 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 13668-527-04 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 13668-527-01 557ba5c1ecfa…9c80585c8c6e…
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 A207899-001 MOMETASONE FUROATE MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2018-07-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207899-001 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 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2018-07-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2018-07-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2018-07-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2018-07-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2018-07-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2018-07-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2018-07-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2018-07-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2018-07-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2018-07-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2018-07-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2018-07-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2018-07-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2018-07-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207899-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL 2018-07-13 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Mometasone Furoate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MOMETASONE FUROATE 1 mg/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 151029 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 13668-527-01 Mometasone Furoate 15 in 1 BOX OINTMENT 15 8 13668-527-04 Mometasone Furoate 45 in 1 BOX OINTMENT 45 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13668-527 MOMETASONE FUROATE OINTMENT [TORRENT PHARMACEUTICALS LIMITED] 7 Current NDC, Legacy NDC, 2 package rows 20250327_18ef90de-f74d-492f-a125-49da1875bd29.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 Marketing end Sample Exclude flag Status 13668-527-01 13668052701 15 OINTMENT in 1 BOX (13668-527-01) 15 ointment 2024-12-15 0000-00-00 No No Current 13668-527-04 13668052704 45 OINTMENT in 1 BOX (13668-527-04) 45 ointment 2024-12-15 0000-00-00 No No Current