Mometasone Furoate

Product NDC: 68788-4075
11-digit product format: 687884075
Labeler code: 68788
Product ID: 68788-4075_ad47cceb-e471-48d6-85d6-e4a3f10e2ac6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mometasone Furoate
Dosage form: CREAM
Route: TOPICAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA077447
Marketing category: ANDA
Marketing start: 2026-01-27
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077447-001	MOMETASONE FUROATE	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2006-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077447-001	AB

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 · 43 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
2026-09-14 22:38:34	2026-08	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2006-05-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2006-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2006-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2006-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2006-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077447-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077447-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077447-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077447-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077447-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077447-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077447-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077447-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077447-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077447-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077447-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077447-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077447-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077447-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077447-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077447-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077447-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077447-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077447-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077447-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077447-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077447-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077447-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077447-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077447-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077447-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077447-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077447-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077447-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077447-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077447-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077447-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077447-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077447-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077447-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077447-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077447-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077447-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077447-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077447-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Mometasone Furoate
Listing expiration: 2027-12-31

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ad47cceb-e471-48d6-85d6-e4a3f10e2ac6	Available on FDA.report

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
68788-4075-4	Mometasone Furoate	45 g in 1 TUBE	CREAM	45		1
68788-4075-4	Mometasone Furoate	1 in 1 CARTON	CREAM	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-4075-4	GM - Gram	68788-4075	ca810260-6ae0-4926-acf3-029946793bcf	1	2026-04-20

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mometasone Furoate	MOMETASONE FUROATE	Preferred Pharmaceuticals Inc.	ad47cceb-e471-48d6-85d6-e4a3f10e2ac6	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077447 application number: ANDA077447 ndc (product): 68788-4075
Mometasone Furoate	MOMETASONE FUROATE	A-S Medication Solutions	16e134c7-39fb-4d16-9c24-a6df438967bf	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077447 application number: ANDA077447
Mometasone Furoate	MOMETASONE FUROATE	Cosette Pharmaceuticals, Inc.	f69603aa-a5a6-b8f3-c9ed-2d0abc9f4d92	2023-11-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077447 application number: ANDA077447

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
311753	mometasone furoate 0.1 % Topical Cream	PSN	ad47cceb-e471-48d6-85d6-e4a3f10e2ac6	1
311753	mometasone furoate 1 MG/ML Topical Cream	SCD	ad47cceb-e471-48d6-85d6-e4a3f10e2ac6	1
311753	mometasone furoate 0.1 % Topical Cream	SY	ad47cceb-e471-48d6-85d6-e4a3f10e2ac6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-4075-4	68788407504	1 TUBE in 1 CARTON (68788-4075-4) / 45 g in 1 TUBE	1 tube	2026-01-27	No	No	Current