Mometasone Furoate

Product NDC: 70518-2883
Requested package NDC: 70518-2883-0
11-digit product format: 705182883
Labeler code: 70518
Product ID: 70518-2883_e39b5293-eb73-f990-e053-2a95a90aaef9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mometasone Furoate
Dosage form: CREAM
Route: TOPICAL
Labeler: REMEDYREPACK INC.
Application: ANDA076679
Marketing category: ANDA
Marketing start: 2020-09-14
Marketing end: 0000-00-00
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: 2023-12-31
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	70518-2883	70518-2883-0	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2883-0	2022-02-08	C162847	48780-1	d6a99b39-c95e-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use MOMETASONE FUROATE CREAM safely and effectively. See full prescribing information for MOMETASONE FUROATE CREAM. MOMETASONE FUROATE cream, for topical use Initial U.S. Approval: 1987
70518-2883-0	2022-01-28	C162847	48780-1	d6a99b39-c95e-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use MOMETASONE FUROATE CREAM safely and effectively. See full prescribing information for MOMETASONE FUROATE CREAM. MOMETASONE FUROATE cream, for topical use Initial U.S. Approval: 1987

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2883-0	70518288300	1 TUBE in 1 CARTON (70518-2883-0) > 15 g in 1 TUBE	1 tube	2020-09-14	0000-00-00	No	No	Current