Mometasone Furoate

Product NDC: 51672-1315
11-digit product format: 516721315
Labeler code: 51672
Product ID: 51672-1315_3961a44e-34f7-d648-e063-6394a90a974e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mometasone Furoate
Dosage form: CREAM
Route: TOPICAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA076679
Marketing category: ANDA
Marketing start: 2004-12-21
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

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: 2026-12-31

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
ce61920d-65df-4423-925d-091e624ea32e	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	SPL version
51672-1315-1	Mometasone Furoate	15 g in 1 TUBE	CREAM	15	6
51672-1315-1	Mometasone Furoate	1 in 1 CARTON	CREAM	1	6
51672-1315-6	Mometasone Furoate	1 in 1 CARTON	CREAM	1	6
51672-1315-6	Mometasone Furoate	45 g in 1 TUBE	CREAM	45	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Mometasone Furoate	ACTIVE INGREDIENT	04201GDN4R	MOMETASONE FUROATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
Mometasone	ACTIVE MOIETY	8HR4QJ6DW8	MOMETASONE FUROATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
ALUMINUM STARCH OCTENYLSUCCINATE	INACTIVE INGREDIENT	I9PJ0O6294	MOMETASONE FUROATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	MOMETASONE FUROATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	MOMETASONE FUROATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	MOMETASONE FUROATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	MOMETASONE FUROATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
PROPYLENE GLYCOL STEARATE	INACTIVE INGREDIENT	MZM1I680W0	MOMETASONE FUROATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	MOMETASONE FUROATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MOMETASONE FUROATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	MOMETASONE FUROATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	MOMETASONE FUROATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-1315	MOMETASONE FUROATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	5	Current NDC, Legacy NDC, 4 package rows	20210211_ce61920d-65df-4423-925d-091e624ea32e.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
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 ndc (product): 51672-1315
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	ce61920d-65df-4423-925d-091e624ea32e	6
311753	mometasone furoate 1 MG/ML Topical Cream	SCD	ce61920d-65df-4423-925d-091e624ea32e	6
311753	mometasone furoate 0.1 % Topical Cream	SY	ce61920d-65df-4423-925d-091e624ea32e	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-1315-1	51672131501	1 TUBE in 1 CARTON (51672-1315-1) / 15 g in 1 TUBE	1 tube	2004-12-21	0000-00-00	No	No	Current
51672-1315-6	51672131506	1 TUBE in 1 CARTON (51672-1315-6) / 45 g in 1 TUBE	1 tube	2004-12-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mometasone Furoate	Sun Pharmaceutical Industries, Inc. \| Sun Pharma Canada Inc.	2025-07-07	HUMAN PRESCRIPTION DRUG LABEL	6