Mometasone Furoate

Product NDC: 68788-8548
11-digit product format: 687888548
Labeler code: 68788
Product ID: 68788-8548_6ca80b32-7739-4ca5-921f-a12cbc51c5f2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mometasone Furoate
Dosage form: CREAM
Route: TOPICAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA076679
Marketing category: ANDA
Marketing start: 2023-11-14
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	68788-8548		U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-8548	68788-8548-4	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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
A076679-001	MOMETASONE FUROATE	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB		2004-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076679-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076679-001	MOMETASONE FUROATE	0.1%	CREAM / TOPICAL	AB	2004-12-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076679-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076679-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076679-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076679-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076679-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076679-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076679-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076679-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076679-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076679-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076679-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076679-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076679-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076679-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076679-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076679-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076679-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076679-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076679-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076679-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076679-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076679-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076679-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076679-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076679-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076679-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076679-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076679-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076679-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076679-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076679-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076679-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076679-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076679-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076679-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076679-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076679-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076679-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076679-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076679-001	AB	1	`e64feba35796…`

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
831f7694-8153-4a79-a453-48020b26f035	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
68788-8548-4	Mometasone Furoate	45 g in 1 TUBE	CREAM	45		2
68788-8548-4	Mometasone Furoate	1 in 1 CARTON	CREAM	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8548-4	GM - Gram	68788-8548	a3450429-618b-4d7c-b4dd-cfef96c21f50	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8548	MOMETASONE FUROATE CREAM [PREFERRED PHARMACEUTICALS INC.]	2	Current NDC, 2 package rows	20250117_831f7694-8153-4a79-a453-48020b26f035.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 · 8 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.	831f7694-8153-4a79-a453-48020b26f035	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076679 application number: ANDA076679 ndc (product): 68788-8548
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	c953bd40-8a52-4812-837a-baaf1b17b3aa	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076679 application number: ANDA076679
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	88f5622d-64da-42b7-8aa9-62a5da5ebfbb	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076679 application number: ANDA076679
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	79e13e15-5bd3-48b1-877a-1cd92abbc7c5	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076679 application number: ANDA076679
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	2f79063c-f7da-4e71-b054-d24b86dd386a	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076679 application number: ANDA076679
Mometasone Furoate	MOMETASONE FUROATE	Padagis Israel Pharmaceuticals Ltd	a12fef6b-681e-4f80-8bcd-3f01733f1a67	2025-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076679 application number: ANDA076679
Mometasone Furoate	MOMETASONE FUROATE	Sun Pharmaceutical Industries, Inc.	ce61920d-65df-4423-925d-091e624ea32e	2025-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076679 application number: ANDA076679
Mometasone Furoate	MOMETASONE FUROATE	Proficient Rx LP	2bf06b19-4ed7-41a3-b6fc-29713c41965c	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076679 application number: ANDA076679

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	831f7694-8153-4a79-a453-48020b26f035	2
311753	mometasone furoate 1 MG/ML Topical Cream	SCD	831f7694-8153-4a79-a453-48020b26f035	2
311753	mometasone furoate 0.1 % Topical Cream	SY	831f7694-8153-4a79-a453-48020b26f035	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8548-4	68788854804	1 TUBE in 1 CARTON (68788-8548-4) / 45 g in 1 TUBE	1 tube	2023-11-14	No	No	Current