Mometasone Furoate

Product NDC
72162-1392
11-digit product format
721621392
Labeler code
72162
Product ID
72162-1392_539d6967-2a14-4c0c-b33d-36fb90682830
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA077180
Marketing category
ANDA
Marketing start
2008-12-11
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077180-001MOMETASONE FUROATEMOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077180-001AB

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 06:07:402026-07A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALAB2005-04-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALAB2005-04-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALAB2005-04-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALAB2005-04-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALAB2005-04-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALAB2005-04-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALAB2005-04-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALAB2005-04-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALAB2005-04-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALAB2005-04-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALAB2005-04-063f01610625f2…
2019-09-15 20:21 UTC2019-09A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALAB2005-04-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALAB2005-04-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALABRS2005-04-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALAB2005-04-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALAB2005-04-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALAB2005-04-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077180-001MOMETASONE FUROATE0.1%LOTION / TOPICALAB2005-04-06e64feba35796…

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 06:07:402026-07A077180-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077180-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077180-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077180-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077180-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077180-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077180-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077180-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077180-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077180-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077180-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077180-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077180-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077180-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077180-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077180-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077180-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077180-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077180-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077180-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077180-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077180-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077180-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077180-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077180-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077180-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077180-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077180-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077180-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077180-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077180-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077180-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077180-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077180-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077180-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077180-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077180-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077180-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077180-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077180-001AB1e64feba35796…

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/mL

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
151030Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d15edb8b-c8b2-4023-992e-f79cefa2d1e8Available 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
72162-1392-3Mometasone Furoate1 in 1 CARTONSOLUTION1100
72162-1392-3Mometasone Furoate30 mL in 1 BOTTLESOLUTION30100
72162-1392-6Mometasone Furoate1 in 1 CARTONSOLUTION1100
72162-1392-6Mometasone Furoate60 mL in 1 BOTTLESOLUTION60100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1392-3ML - Milliliter72162-139282fdeb7c-9af8-4a9d-85fb-81f22ee1e4a412023-09-05
72162-1392-6ML - Milliliter72162-139280c4cf81-367a-4d5e-8968-dd1ee39cf34512023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1392MOMETASONE FUROATE SOLUTION [BRYANT RANCH PREPACK]100Current NDC, 4 package rows20230823_d15edb8b-c8b2-4023-992e-f79cefa2d1e8.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepack6c7d8133-b71e-4290-bec1-53ff0232998a2024-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077180
application number: ANDA077180
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepackd15edb8b-c8b2-4023-992e-f79cefa2d1e82023-08-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077180
application number: ANDA077180
ndc (product): 72162-1392
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepack5f1f2136-9e10-4d43-bb35-ed285c744fe42023-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077180
application number: ANDA077180
Mometasone FuroateMOMETASONE FUROATEPadagis Israel Pharmaceuticals Ltd7296b4a2-f180-4887-a8e0-029f81aec5662023-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077180
application number: ANDA077180

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151030mometasone furoate 0.1 % Topical Solution (Lotion)PSNd15edb8b-c8b2-4023-992e-f79cefa2d1e8100
151030mometasone furoate 1 MG/ML Topical LotionSCDd15edb8b-c8b2-4023-992e-f79cefa2d1e8100
151030mometasone furoate 0.1 % Topical LotionSYd15edb8b-c8b2-4023-992e-f79cefa2d1e8100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1392-3721621392031 BOTTLE in 1 CARTON (72162-1392-3) / 30 mL in 1 BOTTLE1 bottle2023-08-16NoNoCurrent
72162-1392-6721621392061 BOTTLE in 1 CARTON (72162-1392-6) / 60 mL in 1 BOTTLE1 bottle2023-08-16NoNoCurrent