Mometasone Furoate

Product NDC
50090-1633
11-digit product format
500901633
Labeler code
50090
Product ID
50090-1633_80dfa306-3c97-40f6-9d33-fc1a0171867d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA076067
Marketing category
ANDA
Marketing start
2008-07-18
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

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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50090-1633-0fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50090-1633-086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50090-1633-0bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50090-1633-08dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50090-1633-0e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50090-1633-09bebd1f3094a…5416666fcb17…

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
A076067-001MOMETASONE FUROATEMOMETASONE FUROATE0.1%OINTMENT / TOPICALABRS2002-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076067-001AB

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 06:07:402026-07A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALABRS2002-03-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALABRS2002-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALABRS2002-03-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALABRS2002-03-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-183f01610625f2…
2019-09-15 20:21 UTC2019-09A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALAB2002-03-18e64feba35796…

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 06:07:402026-07A076067-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076067-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076067-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076067-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076067-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076067-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076067-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076067-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076067-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076067-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076067-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076067-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076067-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076067-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076067-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076067-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076067-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076067-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076067-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076067-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076067-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076067-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076067-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076067-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076067-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076067-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076067-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076067-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076067-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076067-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076067-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076067-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076067-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076067-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076067-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076067-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076067-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076067-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076067-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076067-001AB1e64feba35796…

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/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
151029Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9fe65193-b4d8-480b-89b3-178cd1b20713Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1633-0Mometasone Furoate15 g in 1 TUBEOINTMENT1510
50090-1633-0Mometasone Furoate1 in 1 CARTONOINTMENT110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1633-0GM - Gram50090-163322f956b9-b00c-435f-ba01-f95ca8ad89d912024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1633MOMETASONE FUROATE OINTMENT [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 2 package rows20230219_9fe65193-b4d8-480b-89b3-178cd1b20713.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mometasone FuroateMOMETASONE FUROATEPreferred Pharmaceuticals Inc.bfe3d098-a5f8-4e5d-9fa6-eac167bad3e92026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076067
application number: ANDA076067
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepack5eda1256-001a-4f40-b3ca-15349d5320332026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076067
application number: ANDA076067
Mometasone FuroateMOMETASONE FUROATESportpharm LLCf02dea3f-9e4f-4c5a-bea3-f428afca803b2026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076067
application number: ANDA076067
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepack43a91066-1d85-4f67-9856-a11c1bb2b22b2024-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076067
application number: ANDA076067
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepack45c9512b-9463-4684-bfdb-742644d77cc32024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076067
application number: ANDA076067
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepackc3053a64-9044-496e-9005-12b4440d46e82023-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076067
application number: ANDA076067
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepacka6055a9c-e19c-48ad-a743-c0a7f7366cdd2023-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076067
application number: ANDA076067
Mometasone FuroateMOMETASONE FUROATEA-S Medication Solutions9fe65193-b4d8-480b-89b3-178cd1b207132023-02-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076067
application number: ANDA076067
ndc (product): 50090-1633
Mometasone FuroateMOMETASONE FUROATEPadagis Israel Pharmaceuticals Ltdd986282f-da3c-43b6-a3f6-40886d4a19152023-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076067
application number: ANDA076067
Mometasone FuroateMOMETASONE FUROATEProficient Rx LPc08fcb0d-7fff-4d90-aeb8-e912b930bf3d2020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076067
application number: ANDA076067

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151029mometasone furoate 0.1 % Topical OintmentPSN9fe65193-b4d8-480b-89b3-178cd1b2071310
151029mometasone furoate 0.001 MG/MG Topical OintmentSCD9fe65193-b4d8-480b-89b3-178cd1b2071310
151029mometasone furoate 0.1 % Topical OintmentSY9fe65193-b4d8-480b-89b3-178cd1b2071310
151029mometasone furoate 1 MG/GM Topical OintmentSY9fe65193-b4d8-480b-89b3-178cd1b2071310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-1633-0500901633001 TUBE in 1 CARTON (50090-1633-0) / 15 g in 1 TUBE1 tube2015-01-15NoNoCurrent