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 1.

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.

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
2025-01-19 17:59 UTC	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…`
2022-09-29 23:25 UTC	2022-09	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2006-05-22	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A077447-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	RS	2006-05-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-01-19 17:59 UTC	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…`
2022-09-29 23:25 UTC	2022-09	A077447-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077447-001	AB	1	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A077447-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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