Home NDC 68462-192 Mometasone Furoate
Product NDC 68462-192
11-digit product format 684620192
Labeler code 68462
Product ID 68462-192_42b90831-6019-4d81-aa0d-6fb75c4d51a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mometasone Furoate
Dosage form CREAM
Route TOPICAL
Labeler Glenmark Pharmaceuticals Inc., USA
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078541-001 MOMETASONE FUROATE MOMETASONE FUROATE 0.1% CREAM / TOPICAL 2008-05-28
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL 2008-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL 2008-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL 2008-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL 2008-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB 2008-05-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078541-001 MOMETASONE FUROATE 0.1% CREAM / TOPICAL AB RS 2008-05-28 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Mometasone Furoate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MOMETASONE FUROATE 1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04201GDN4R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311753 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68462-192-17 Mometasone Furoate 15 g in 1 TUBE CREAM 15 10 68462-192-55 Mometasone Furoate 45 g in 1 TUBE CREAM 45 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MOMETASONE FUROATE ACTIVE INGREDIENT 04201GDN4R MOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 MOMETASONE ACTIVE MOIETY 8HR4QJ6DW8 MOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 ALUMINUM STARCH OCTENYLSUCCINATE INACTIVE INGREDIENT I9PJ0O6294 MOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 HEXYLENE GLYCOL INACTIVE INGREDIENT KEH0A3F75J MOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U MOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN MOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 POLYOXYL 20 CETOSTEARYL ETHER INACTIVE INGREDIENT YRC528SWUY MOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 PROPYLENE GLYCOL STEARATE INACTIVE INGREDIENT MZM1I680W0 MOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y MOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 WATER INACTIVE INGREDIENT 059QF0KO0R MOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 WHITE WAX INACTIVE INGREDIENT 7G1J5DA97F MOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 5 MOMETASONE FUROATE ACTIVE INGREDIENT 04201GDN4R MOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 MOMETASONE FUROATE ACTIVE INGREDIENT 04201GDN4R MOMETASONE FUROATE CREAM [PROFICIENT RX LP] 1 MOMETASONE ACTIVE MOIETY 8HR4QJ6DW8 MOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 MOMETASONE ACTIVE MOIETY 8HR4QJ6DW8 MOMETASONE FUROATE CREAM [PROFICIENT RX LP] 1 ALUMINUM STARCH OCTENYLSUCCINATE INACTIVE INGREDIENT I9PJ0O6294 MOMETASONE FUROATE CREAM [PROFICIENT RX LP] 1 ALUMINUM STARCH OCTENYLSUCCINATE INACTIVE INGREDIENT I9PJ0O6294 MOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 HEXYLENE GLYCOL INACTIVE INGREDIENT KEH0A3F75J MOMETASONE FUROATE CREAM [PROFICIENT RX LP] 1 HEXYLENE GLYCOL INACTIVE INGREDIENT KEH0A3F75J MOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U MOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U MOMETASONE FUROATE CREAM [PROFICIENT RX LP] 1 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN MOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN MOMETASONE FUROATE CREAM [PROFICIENT RX LP] 1 POLYOXYL 20 CETOSTEARYL ETHER INACTIVE INGREDIENT YRC528SWUY MOMETASONE FUROATE CREAM [PROFICIENT RX LP] 1 PROPYLENE GLYCOL MONOSTEARATE INACTIVE INGREDIENT F76354LMGR MOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL STEARATE INACTIVE INGREDIENT MZM1I680W0 MOMETASONE FUROATE CREAM [PROFICIENT RX LP] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y MOMETASONE FUROATE CREAM [PROFICIENT RX LP] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y MOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MOMETASONE FUROATE CREAM [PROFICIENT RX LP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R MOMETASONE FUROATE CREAM [PROFICIENT RX LP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R MOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1 WHITE WAX INACTIVE INGREDIENT 7G1J5DA97F MOMETASONE FUROATE CREAM [PROFICIENT RX LP] 1 WHITE WAX INACTIVE INGREDIENT 7G1J5DA97F MOMETASONE FUROATE CREAM [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-192 MOMETASONE FUROATE CREAM [GLENMARK PHARMACEUTICALS INC., USA] 10 Current NDC, Legacy NDC, 2 package rows 20240104_031283ed-988b-4698-8a2e-00f3d41c0f71.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68462-192-17 68462019217 15 g in 1 TUBE (68462-192-17) 15 g 2008-05-28 0000-00-00 No No Current 68462-192-55 68462019255 45 g in 1 TUBE (68462-192-55) 45 g 2008-05-28 0000-00-00 No No Current