Mometasone Furoate

Product NDC: 68462-225
11-digit product format: 684620225
Labeler code: 68462
Product ID: 68462-225_68dd082e-2bd7-43d5-9dd2-948bd2cd4637
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mometasone furoate
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA078571
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

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68462-225		D	Discontinued by firm	2026-08-17
excluded package	package	68462-225	68462-225-17	D	Discontinued by firm	2026-08-17
excluded package	package	68462-225	68462-225-55	D	Discontinued by firm	2026-08-17

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078571-001	MOMETASONE FUROATE	MOMETASONE FUROATE	0.1%	OINTMENT / 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	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL			2008-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL			2008-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL			2008-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL			2008-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB		2008-05-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078571-001	MOMETASONE FUROATE	0.1%	OINTMENT / TOPICAL	AB	RS	2008-05-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078571-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078571-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078571-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078571-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078571-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078571-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078571-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078571-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078571-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078571-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078571-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078571-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078571-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078571-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078571-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078571-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078571-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078571-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078571-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078571-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078571-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078571-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078571-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078571-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078571-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078571-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078571-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078571-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078571-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078571-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078571-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078571-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078571-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078571-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078571-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078571-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078571-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
624001e0-0eba-4aac-a60c-c2ecb37d4f08	Product name	1	20220927
1cbe9071-502b-482d-9c24-839b43446576	Product name	1	20200123
ce567bde-218c-2386-f79b-42addb0c34fb	Product name	2	20180829
1e8b10fc-5c6a-4af6-9363-4bda9402a4f4	Product name	1	20180209
fa8c1c3a-f36c-46b1-b4f1-4e877f3dcb1d	Product name	2	20170613
511188c3-b8c1-4966-aa31-5463cfd4fa48	Product name	1	20141222
6dcdf27c-6d6a-2465-ccae-faeb308e8070	Product name	1	20140508
aca60174-7f12-2753-ec74-0eb827cf0776	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68462-225-17	Mometasone Furoate	15 g in 1 TUBE	OINTMENT	15		7
68462-225-55	Mometasone Furoate	45 g in 1 TUBE	OINTMENT	45		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-225-17	GM - Gram	68462-225	6534eaac-fd1e-4b6f-87c3-eac16f38225c	1	2012-07-24
68462-225-55	GM - Gram	68462-225	cd05156a-4080-434e-9fb1-ea73ca6fba07	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MOMETASONE FUROATE	ACTIVE INGREDIENT	04201GDN4R	MOMETASONE FUROATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]	3
MOMETASONE	ACTIVE MOIETY	8HR4QJ6DW8	MOMETASONE FUROATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]	3
HEXYLENE GLYCOL	INACTIVE INGREDIENT	KEH0A3F75J	MOMETASONE FUROATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]	3
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	MOMETASONE FUROATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]	3
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	MOMETASONE FUROATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]	3
PROPYLENE GLYCOL MONOPALMITOSTEARATE	INACTIVE INGREDIENT	F76354LMGR	MOMETASONE FUROATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	MOMETASONE FUROATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]	3
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	MOMETASONE FUROATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-225	MOMETASONE FUROATE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]	7	Current NDC, Legacy NDC, 2 package rows	20240104_209c15dd-72b2-4f00-a2f0-011219f7eaea.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04201GDN4R	MOMETASONE FUROATE	83919-23-7	MOMETASONE FUROATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
151029	mometasone furoate 0.1 % Topical Ointment	PSN	209c15dd-72b2-4f00-a2f0-011219f7eaea	7
151029	mometasone furoate 0.1 % Topical Ointment	PSN	6e1d81d2-9e07-40d4-8f52-859f26c3776b	7
151029	mometasone furoate 0.001 MG/MG Topical Ointment	SCD	209c15dd-72b2-4f00-a2f0-011219f7eaea	7
151029	mometasone furoate 0.001 MG/MG Topical Ointment	SCD	6e1d81d2-9e07-40d4-8f52-859f26c3776b	7
151029	mometasone furoate 0.1 % Topical Ointment	SY	209c15dd-72b2-4f00-a2f0-011219f7eaea	7
151029	mometasone furoate 0.1 % Topical Ointment	SY	6e1d81d2-9e07-40d4-8f52-859f26c3776b	7
151029	mometasone furoate 1 MG/GM Topical Ointment	SY	209c15dd-72b2-4f00-a2f0-011219f7eaea	7
151029	mometasone furoate 1 MG/GM Topical Ointment	SY	6e1d81d2-9e07-40d4-8f52-859f26c3776b	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-225-17	68462022517	15 g in 1 TUBE (68462-225-17)	15 g	2008-05-28	0000-00-00	No	No	Current
68462-225-55	68462022555	45 g in 1 TUBE (68462-225-55)	45 g	2008-05-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mometasone Furoate	A-S Medication Solutions	2021-08-25	HUMAN PRESCRIPTION DRUG LABEL	7
Mometasone Furoate	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2021-02-23	HUMAN PRESCRIPTION DRUG LABEL	7
Mometasone Furoate	NuCare Pharmaceuticals,Inc.	2021-02-22	HUMAN PRESCRIPTION DRUG LABEL	3