Mometasone Furoate

Product NDC
67405-100
11-digit product format
674050100
Labeler code
67405
Product ID
67405-100_d16b87bc-3f19-45c9-a34d-c6b1b2d70394
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
CREAM
Route
TOPICAL
Labeler
Harris Pharmaceutical, Inc.
Application
ANDA077447
Marketing category
ANDA
Marketing start
2006-08-23
Marketing end
0000-00-00
Substance
MOMETASONE FUROATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67405-100DDiscontinued by firm2026-08-17
excluded packagepackage67405-10067405-100-15DDiscontinued by firm2026-08-17
excluded packagepackage67405-10067405-100-45DDiscontinued by firm2026-08-17

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67405-100-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67405-100-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67405-100-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67405-100-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67405-100-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67405-100-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67405-100-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67405-100-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67405-100-45cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67405-100-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67405-100-45cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67405-100-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67405-100-45302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67405-100-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67405-100-45ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67405-100-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67405-100-450efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67405-100-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67405-100-45ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67405-100-15ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67405-100-45367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67405-100-15367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67405-100-45557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67405-100-15557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077447-001MOMETASONE FUROATEMOMETASONE FUROATE0.1%CREAM / TOPICALABRS2006-05-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A077447-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2006-05-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2006-05-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2006-05-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2006-05-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-223f01610625f2…
2019-09-15 20:21 UTC2019-09A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077447-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2006-05-22e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077447-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077447-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077447-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077447-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077447-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077447-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077447-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077447-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077447-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077447-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077447-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077447-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077447-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077447-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077447-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077447-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077447-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077447-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077447-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077447-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077447-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077447-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077447-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077447-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077447-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077447-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077447-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077447-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077447-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077447-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077447-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077447-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077447-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077447-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077447-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077447-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077447-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077447-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077447-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077447-001AB1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
1cbe9071-502b-482d-9c24-839b43446576Product name120200123
ce567bde-218c-2386-f79b-42addb0c34fbProduct name220180829
1e8b10fc-5c6a-4af6-9363-4bda9402a4f4Product name120180209
fa8c1c3a-f36c-46b1-b4f1-4e877f3dcb1dProduct name220170613
511188c3-b8c1-4966-aa31-5463cfd4fa48Product name120141222
6dcdf27c-6d6a-2465-ccae-faeb308e8070Product name120140508
aca60174-7f12-2753-ec74-0eb827cf0776Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67405-100-15GM - Gram67405-1004fcf2c47-cc9b-486a-bbcc-e99729ba046412012-07-24
67405-100-45GM - Gram67405-100b54aa044-8186-4ec5-bf54-8106b0b6480e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MOMETASONE FUROATEACTIVE INGREDIENT04201GDN4RMOMETASONE FUROATE CREAM [STAT RX USA LLC]1
MOMETASONE FUROATEACTIVE MOIETY04201GDN4RMOMETASONE FUROATE CREAM [STAT RX USA LLC]1
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JMOMETASONE FUROATE CREAM [STAT RX USA LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UMOMETASONE FUROATE CREAM [STAT RX USA LLC]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNMOMETASONE FUROATE CREAM [STAT RX USA LLC]1
PROPYLENE GLYCOL MONOSTEARATEINACTIVE INGREDIENTF76354LMGRMOMETASONE FUROATE CREAM [STAT RX USA LLC]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YMOMETASONE FUROATE CREAM [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMOMETASONE FUROATE CREAM [STAT RX USA LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RMOMETASONE FUROATE CREAM [STAT RX USA LLC]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FMOMETASONE FUROATE CREAM [STAT RX USA LLC]1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mometasone FuroateMOMETASONE FUROATEPreferred Pharmaceuticals Inc.ad47cceb-e471-48d6-85d6-e4a3f10e2ac62026-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077447
application number: ANDA077447
Mometasone FuroateMOMETASONE FUROATEA-S Medication Solutions16e134c7-39fb-4d16-9c24-a6df438967bf2026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077447
application number: ANDA077447
Mometasone FuroateMOMETASONE FUROATECosette Pharmaceuticals, Inc.f69603aa-a5a6-b8f3-c9ed-2d0abc9f4d922023-11-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077447
application number: ANDA077447

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311753mometasone furoate 0.1 % Topical CreamPSNc337bce8-27e9-48fd-85fa-381d0242a36a1
311753mometasone furoate 1 MG/ML Topical CreamSCDc337bce8-27e9-48fd-85fa-381d0242a36a1
311753mometasone furoate 0.1 % Topical CreamSYc337bce8-27e9-48fd-85fa-381d0242a36a1