FDA.reportPublic FDA data

Mometasone Furoate

Product NDC
51672-1311
11-digit product format
516721311
Labeler code
51672
Product ID
51672-1311_39619c2c-5804-85d9-e063-6294a90aa109
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA076624
Marketing category
ANDA
Marketing start
2004-12-03
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

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 productproduct51672-1311DDiscontinued by firm2026-08-17
excluded packagepackage51672-131151672-1311-1DDiscontinued by firm2026-08-17
excluded packagepackage51672-131151672-1311-6DDiscontinued by firm2026-08-17

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
A076624-001MOMETASONE FUROATEMOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-03

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 06:07:402026-07A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-033f01610625f2…
2019-09-15 20:21 UTC2019-09A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076624-001MOMETASONE FUROATE0.1%OINTMENT / TOPICAL2004-12-03e64feba35796…

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
51672-1311-1Mometasone Furoate15 g in 1 TUBEOINTMENT155
51672-1311-1Mometasone Furoate1 in 1 CARTONOINTMENT15
51672-1311-6Mometasone Furoate1 in 1 CARTONOINTMENT15
51672-1311-6Mometasone Furoate45 g in 1 TUBEOINTMENT455

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Mometasone FuroateACTIVE INGREDIENT04201GDN4RMOMETASONE FUROATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
MometasoneACTIVE MOIETY8HR4QJ6DW8MOMETASONE FUROATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
hexylene glycolINACTIVE INGREDIENTKEH0A3F75JMOMETASONE FUROATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UMOMETASONE FUROATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycol stearateINACTIVE INGREDIENTMZM1I680W0MOMETASONE FUROATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
white waxINACTIVE INGREDIENT7G1J5DA97FMOMETASONE FUROATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1311MOMETASONE FUROATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4Current NDC, Legacy NDC, 4 package rows20181010_d8cf50d4-0448-4527-a498-cddd511213f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151029mometasone furoate 0.1 % Topical OintmentPSNd8cf50d4-0448-4527-a498-cddd511213f05
151029mometasone furoate 0.001 MG/MG Topical OintmentSCDd8cf50d4-0448-4527-a498-cddd511213f05
151029mometasone furoate 0.1 % Topical OintmentSYd8cf50d4-0448-4527-a498-cddd511213f05
151029mometasone furoate 1 MG/GM Topical OintmentSYd8cf50d4-0448-4527-a498-cddd511213f05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1311-1516721311011 TUBE in 1 CARTON (51672-1311-1) / 15 g in 1 TUBE1 tube2004-12-030000-00-00NoNoCurrent
51672-1311-6516721311061 TUBE in 1 CARTON (51672-1311-6) / 45 g in 1 TUBE1 tube2004-12-030000-00-00NoNoCurrent