Mometasone Furoate

Product NDC: 63629-8685
11-digit product format: 636298685
Labeler code: 63629
Product ID: 63629-8685_8a2a552e-8cc7-4a5b-9921-ab917a040962
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mometasone Furoate
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Bryant Ranch Prepack
Application: ANDA077180
Marketing category: ANDA
Marketing start: 2008-12-11
Substance: MOMETASONE FUROATE
Active strength: 1 mg/mL
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
A077180-001	MOMETASONE FUROATE	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077180-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB	RS	2005-04-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077180-001	MOMETASONE FUROATE	0.1%	LOTION / TOPICAL	AB		2005-04-06	`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	A077180-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077180-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077180-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077180-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077180-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077180-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077180-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077180-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077180-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077180-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077180-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077180-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077180-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077180-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077180-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077180-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077180-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077180-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077180-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077180-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077180-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077180-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077180-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077180-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077180-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077180-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077180-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077180-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077180-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077180-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077180-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077180-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077180-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077180-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077180-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077180-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077180-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077180-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077180-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077180-001	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/mL

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
151030	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
5f1f2136-9e10-4d43-bb35-ed285c744fe4	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
63629-8685-1	Mometasone Furoate	1 in 1 CARTON	SOLUTION	1		105
63629-8685-1	Mometasone Furoate	30 mL in 1 BOTTLE	SOLUTION	30		105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8685-1	ML - Milliliter	63629-8685	1bd18968-384f-4b03-957e-02d4679a1b05	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8685	MOMETASONE FUROATE SOLUTION [BRYANT RANCH PREPACK]	105	Current NDC, Legacy NDC, 2 package rows	20240814_5f1f2136-9e10-4d43-bb35-ed285c744fe4.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	6c7d8133-b71e-4290-bec1-53ff0232998a	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077180 application number: ANDA077180
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	d15edb8b-c8b2-4023-992e-f79cefa2d1e8	2023-08-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077180 application number: ANDA077180
Mometasone Furoate	MOMETASONE FUROATE	Bryant Ranch Prepack	5f1f2136-9e10-4d43-bb35-ed285c744fe4	2023-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077180 application number: ANDA077180 ndc (product): 63629-8685
Mometasone Furoate	MOMETASONE FUROATE	Padagis Israel Pharmaceuticals Ltd	7296b4a2-f180-4887-a8e0-029f81aec566	2023-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077180 application number: ANDA077180

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
151030	mometasone furoate 0.1 % Topical Solution (Lotion)	PSN	5f1f2136-9e10-4d43-bb35-ed285c744fe4	105
151030	mometasone furoate 1 MG/ML Topical Lotion	SCD	5f1f2136-9e10-4d43-bb35-ed285c744fe4	105
151030	mometasone furoate 0.1 % Topical Lotion	SY	5f1f2136-9e10-4d43-bb35-ed285c744fe4	105

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8685-1	63629868501	1 BOTTLE in 1 CARTON (63629-8685-1) / 30 mL in 1 BOTTLE	1 bottle	2009-02-02	0000-00-00	No	No	Current