Mometasone Furoate

Product NDC: 68462-385
Requested package NDC: 68462-385-02
11-digit product format: 684620385
Labeler code: 68462
Product ID: 68462-385_126901b5-73a3-477a-81f2-61a373806f7f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mometasone Furoate
Dosage form: LOTION
Route: TOPICAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA090506
Marketing category: ANDA
Marketing start: 2020-06-01
Marketing end: 0000-00-00
Substance: MOMETASONE FUROATE
Active strength: 1 mg/mL
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68462-385	68462-385-02	D	Discontinued by firm		2026-11-06

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A090506-001	MOMETASONE FUROATE	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL			2010-08-09

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2010-08-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2010-08-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2010-08-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2010-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2010-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL		2010-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090506-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	2010-08-09	`3a93d1ddd44b…`

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	A090506-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090506-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090506-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090506-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090506-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090506-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090506-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090506-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090506-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090506-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090506-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090506-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090506-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090506-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090506-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090506-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090506-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090506-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090506-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090506-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090506-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090506-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090506-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090506-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090506-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090506-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090506-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090506-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090506-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090506-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090506-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090506-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090506-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090506-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090506-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090506-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090506-001	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
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	SPL version
68462-385-02	Mometasone Furoate	60 mL in 1 BOTTLE	LOTION	60	10
68462-385-02	Mometasone Furoate	1 in 1 CARTON	LOTION	1	10
68462-385-37	Mometasone Furoate	1 in 1 CARTON	LOTION	1	10
68462-385-37	Mometasone Furoate	30 mL in 1 BOTTLE	LOTION	30	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-385-02	ML - Milliliter	68462-385	c1612a70-8d24-4b0f-b9c8-862df40b4162	1	2012-07-24
68462-385-37	ML - Milliliter	68462-385	86a308c1-d2b8-4220-bd29-8883ad0183a0	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 LOTION [GLENMARK PHARMACEUTICALS INC., USA]	4
MOMETASONE	ACTIVE MOIETY	8HR4QJ6DW8	MOMETASONE FUROATE LOTION [GLENMARK PHARMACEUTICALS INC., USA]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MOMETASONE FUROATE LOTION [GLENMARK PHARMACEUTICALS INC., USA]	4
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	MOMETASONE FUROATE LOTION [GLENMARK PHARMACEUTICALS INC., USA]	4
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	MOMETASONE FUROATE LOTION [GLENMARK PHARMACEUTICALS INC., USA]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	MOMETASONE FUROATE LOTION [GLENMARK PHARMACEUTICALS INC., USA]	4
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	MOMETASONE FUROATE LOTION [GLENMARK PHARMACEUTICALS INC., USA]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	MOMETASONE FUROATE LOTION [GLENMARK PHARMACEUTICALS INC., USA]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-385	MOMETASONE FUROATE LOTION [GLENMARK PHARMACEUTICALS INC., USA]	10	Legacy NDC, 4 package rows	20240104_96eafc06-0354-49ca-a684-a77bb2afc8f5.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
151030	mometasone furoate 0.1 % Topical Solution (Lotion)	PSN	96eafc06-0354-49ca-a684-a77bb2afc8f5	10
151030	mometasone furoate 1 MG/ML Topical Lotion	SCD	96eafc06-0354-49ca-a684-a77bb2afc8f5	10
151030	mometasone furoate 0.1 % Topical Lotion	SY	96eafc06-0354-49ca-a684-a77bb2afc8f5	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-385-02	68462038502	1 BOTTLE in 1 CARTON (68462-385-02) > 60 mL in 1 BOTTLE	1 bottle	2020-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mometasone Furoate	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2020-05-31	HUMAN PRESCRIPTION DRUG LABEL	10