Mometasone Furoate

Product NDC
63187-432
11-digit product format
631870432
Labeler code
63187
Product ID
63187-432_19190e62-634d-45bb-9f9b-e0f0a4608e98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA078541
Marketing category
ANDA
Marketing start
2008-05-28
Substance
MOMETASONE FUROATE
Active strength
1 mg/g
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078541-001MOMETASONE FUROATEMOMETASONE FUROATE0.1%CREAM / TOPICAL2008-05-28

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 06:07:402026-07A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICAL2008-05-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICAL2008-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICAL2008-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICAL2008-05-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-283f01610625f2…
2019-09-15 20:21 UTC2019-09A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALAB2008-05-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078541-001MOMETASONE FUROATE0.1%CREAM / TOPICALABRS2008-05-28e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078541-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078541-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078541-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078541-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078541-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078541-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078541-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078541-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078541-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078541-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078541-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078541-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078541-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078541-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078541-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078541-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078541-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078541-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078541-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078541-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078541-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078541-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078541-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078541-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078541-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078541-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078541-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078541-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078541-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078541-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078541-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078541-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078541-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078541-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078541-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078541-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078541-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Mometasone Furoate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOMETASONE FUROATE1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04201GDN4RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311753Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
47a60763-671e-413b-b962-f7f11ba2f4d7Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-432-15Mometasone Furoate15 g in 1 TUBECREAM153

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MOMETASONE FUROATEACTIVE INGREDIENT04201GDN4RMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
MOMETASONEACTIVE MOIETY8HR4QJ6DW8MOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
ALUMINUM STARCH OCTENYLSUCCINATEINACTIVE INGREDIENTI9PJ0O6294MOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
PROPYLENE GLYCOL STEARATEINACTIVE INGREDIENTMZM1I680W0MOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FMOMETASONE FUROATE CREAM [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-432MOMETASONE FUROATE CREAM [PROFICIENT RX LP]3Current NDC, Legacy NDC, 1 package rows20210115_47a60763-671e-413b-b962-f7f11ba2f4d7.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mometasone FuroateMOMETASONE FUROATEProficient Rx LP47a60763-671e-413b-b962-f7f11ba2f4d72021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078541
application number: ANDA078541
ndc (product): 63187-432
Mometasone FuroateMOMETASONE FUROATEGlenmark Pharmaceuticals Inc., USA031283ed-988b-4698-8a2e-00f3d41c0f712019-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078541
application number: ANDA078541

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311753mometasone furoate 0.1 % Topical CreamPSN47a60763-671e-413b-b962-f7f11ba2f4d73
311753mometasone furoate 1 MG/ML Topical CreamSCD47a60763-671e-413b-b962-f7f11ba2f4d73
311753mometasone furoate 0.1 % Topical CreamSY47a60763-671e-413b-b962-f7f11ba2f4d73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-432-156318704321515 g in 1 TUBE (63187-432-15) 15 g2019-01-010000-00-00NoNoCurrent