Dulera

Product NDC: 0085-4610
Requested package NDC: 0085-4610-01
11-digit product format: 000854610
Labeler code: 0085
Product ID: 0085-4610_1ef5a40c-4197-4f13-aec6-51c20412bbad
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mometasone furoate and formoterol fumarate dihydrate
Dosage form: AEROSOL
Route: RESPIRATORY (INHALATION)
Labeler: Merck Sharp & Dohme Corp.
Application: NDA022518
Marketing category: NDA
Marketing start: 2010-06-22
Marketing end: 0000-00-00
Substance: MOMETASONE FUROATE; FORMOTEROL FUMARATE
Active strength: 200 ug/1; ug/1
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	0085-4610	0085-4610-01	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022518-001	DULERA	FORMOTEROL FUMARATE; MOMETASONE FUROATE	0.005MG/INH;0.1MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22
N022518-002	DULERA	FORMOTEROL FUMARATE; MOMETASONE FUROATE	0.005MG/INH;0.2MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22
N022518-003	DULERA	FORMOTEROL FUMARATE; MOMETASONE FUROATE	0.005MG/INH;0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12

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 4 · 125 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022518-001	DULERA	0.005MG/INH;0.1MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022518-002	DULERA	0.005MG/INH;0.2MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022518-003	DULERA	0.005MG/INH;0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022518-001	DULERA	0.005MG/INH;0.1MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022518-002	DULERA	0.005MG/INH;0.2MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022518-003	DULERA	0.005MG/INH;0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022518-001	DULERA	0.005MG/INH;0.1MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022518-002	DULERA	0.005MG/INH;0.2MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022518-003	DULERA	0.005MG/INH;0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022518-001	DULERA	0.005MG/INH;0.1MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022518-002	DULERA	0.005MG/INH;0.2MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022518-003	DULERA	0.005MG/INH;0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022518-001	DULERA	0.005MG/INH;0.1MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022518-002	DULERA	0.005MG/INH;0.2MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022518-003	DULERA	0.005MG/INH;0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022518-001	DULERA	0.005MG/INH;0.1MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022518-002	DULERA	0.005MG/INH;0.2MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022518-003	DULERA	0.005MG/INH;0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022518-001	DULERA	0.005MG/INH;0.1MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022518-002	DULERA	0.005MG/INH;0.2MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022518-003	DULERA	0.005MG/INH;0.05MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2019-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022518-001	DULERA	0.005MG/INH;0.1MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022518-002	DULERA	0.005MG/INH;0.2MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022518-003	DULERA	0.005MG/INH;0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022518-001	DULERA	0.005MG/INH;0.1MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022518-002	DULERA	0.005MG/INH;0.2MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022518-003	DULERA	0.005MG/INH;0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022518-001	DULERA	0.005MG/INH;0.1MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022518-002	DULERA	0.005MG/INH;0.2MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022518-003	DULERA	0.005MG/INH;0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022518-001	DULERA	0.005MG/INH;0.1MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022518-002	DULERA	0.005MG/INH;0.2MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022518-003	DULERA	0.005MG/INH;0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022518-001	DULERA	0.005MG/INH;0.1MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022518-002	DULERA	0.005MG/INH;0.2MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022518-003	DULERA	0.005MG/INH;0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022518-001	DULERA	0.005MG/INH;0.1MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022518-002	DULERA	0.005MG/INH;0.2MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022518-003	DULERA	0.005MG/INH;0.05MG/INH	AEROSOL, METERED / INHALATION	RLD	2019-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022518-001	DULERA	0.005MG/INH;0.1MG/INH	AEROSOL, METERED / INHALATION	RLD, RS	2010-06-22	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022518-001	7067502	2020-05-21	U-1068	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022518-001	7566705	2020-05-21	U-1068	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022518-001	7067502*PED	2020-11-21		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022518-001	7566705*PED	2020-11-21		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022518-002	7067502	2020-05-21	U-1068	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022518-002	7566705	2020-05-21	U-1068	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022518-002	7067502*PED	2020-11-21		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022518-002	7566705*PED	2020-11-21		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N022518-001	7067502	2020-05-21	U-1068	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022518-001	7566705	2020-05-21	U-1068	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022518-001	7067502*PED	2020-11-21		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022518-001	7566705*PED	2020-11-21		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022518-002	7067502	2020-05-21	U-1068	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022518-002	7566705	2020-05-21	U-1068	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022518-002	7067502*PED	2020-11-21		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022518-002	7566705*PED	2020-11-21		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022518-001	7067502	2020-05-21	U-1068	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022518-001	7566705	2020-05-21	U-1068	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022518-001	7067502*PED	2020-11-21		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022518-001	7566705*PED	2020-11-21		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022518-002	7067502	2020-05-21	U-1068	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022518-002	7566705	2020-05-21	U-1068	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022518-002	7067502*PED	2020-11-21		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022518-002	7566705*PED	2020-11-21		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022518-001	7067502	2020-05-21	U-1068	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022518-001	7566705	2020-05-21	U-1068	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022518-001	7067502*PED	2020-11-21		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022518-001	7566705*PED	2020-11-21		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022518-002	7067502	2020-05-21	U-1068	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022518-002	7566705	2020-05-21	U-1068	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022518-002	7067502*PED	2020-11-21		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022518-002	7566705*PED	2020-11-21		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022518-001	7067502	2020-05-21	U-1068	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022518-001	7566705	2020-05-21	U-1068	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022518-001	7067502*PED	2020-11-21		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022518-001	7566705*PED	2020-11-21		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022518-002	7067502	2020-05-21	U-1068	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022518-002	7566705	2020-05-21	U-1068	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022518-002	7067502*PED	2020-11-21		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022518-002	7566705*PED	2020-11-21		Pediatric extension	`b00525d2431f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022518-003	NS	2022-08-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022518-003	PED	2023-02-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022518-003	NS	2022-08-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022518-003	PED	2023-02-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022518-003	NS	2022-08-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022518-003	PED	2023-02-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022518-001	M-214	2020-12-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022518-001	PED	2021-06-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022518-002	M-214	2020-12-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022518-002	PED	2021-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022518-003	NS	2022-08-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022518-003	PED	2023-02-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022518-001	PED	2021-06-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022518-002	PED	2021-06-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022518-003	NS	2022-08-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022518-003	PED	2023-02-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022518-001	PED	2021-06-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022518-002	PED	2021-06-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022518-003	NS	2022-08-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022518-003	PED	2023-02-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022518-001	PED	2021-06-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022518-002	PED	2021-06-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022518-003	NS	2022-08-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022518-003	PED	2023-02-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022518-001	M-214	2020-12-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022518-001	PED	2021-06-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022518-002	M-214	2020-12-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022518-002	PED	2021-06-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022518-001	M-214	2020-12-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022518-001	PED	2021-06-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022518-002	M-214	2020-12-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022518-002	PED	2021-06-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022518-001	M-214	2020-12-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022518-001	PED	2021-06-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022518-002	M-214	2020-12-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022518-002	PED	2021-06-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022518-001	M-214	2020-12-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022518-001	PED	2021-06-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022518-002	M-214	2020-12-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022518-002	PED	2021-06-20	`b00525d2431f…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0085-4610-01	2020-08-04	These highlights do not include all the information needed to use DULERA safely and effectively. See full prescribing information for DULERA. DULERA® (mometasone furoate and formoterol fumarate dihydrate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 2010
0085-4610-02	2020-08-04	These highlights do not include all the information needed to use DULERA safely and effectively. See full prescribing information for DULERA. DULERA® (mometasone furoate and formoterol fumarate dihydrate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 2010
0085-4610-05	2020-08-04	These highlights do not include all the information needed to use DULERA safely and effectively. See full prescribing information for DULERA. DULERA® (mometasone furoate and formoterol fumarate dihydrate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 2010
0085-4610-06	2020-08-04	These highlights do not include all the information needed to use DULERA safely and effectively. See full prescribing information for DULERA. DULERA® (mometasone furoate and formoterol fumarate dihydrate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 2010
0085-4610-01	2020-07-22	These highlights do not include all the information needed to use DULERA safely and effectively. See full prescribing information for DULERA. DULERA® (mometasone furoate and formoterol fumarate dihydrate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 2010
0085-4610-02	2020-07-22	These highlights do not include all the information needed to use DULERA safely and effectively. See full prescribing information for DULERA. DULERA® (mometasone furoate and formoterol fumarate dihydrate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 2010
0085-4610-05	2020-07-22	These highlights do not include all the information needed to use DULERA safely and effectively. See full prescribing information for DULERA. DULERA® (mometasone furoate and formoterol fumarate dihydrate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 2010
0085-4610-06	2020-07-22	These highlights do not include all the information needed to use DULERA safely and effectively. See full prescribing information for DULERA. DULERA® (mometasone furoate and formoterol fumarate dihydrate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 2010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0085-4610-01	GM - Gram	0085-4610	3c02a221-02f0-4b4b-b4ad-f34b069a872e	1	2012-07-24
0085-4610-05	GM - Gram	0085-4610	653a98a5-9fed-49e1-a4c6-909aea50d6ac	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
formoterol fumarate	ACTIVE INGREDIENT	W34SHF8J2K	DULERA (MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [MERCK SHARP & DOHME CORP.]	24
mometasone furoate	ACTIVE INGREDIENT	04201GDN4R	DULERA (MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [MERCK SHARP & DOHME CORP.]	24
formoterol	ACTIVE MOIETY	5ZZ84GCW8B	DULERA (MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [MERCK SHARP & DOHME CORP.]	24
mometasone	ACTIVE MOIETY	8HR4QJ6DW8	DULERA (MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [MERCK SHARP & DOHME CORP.]	24
alcohol	INACTIVE INGREDIENT	3K9958V90M	DULERA (MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [MERCK SHARP & DOHME CORP.]	24
oleic acid	INACTIVE INGREDIENT	2UMI9U37CP	DULERA (MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [MERCK SHARP & DOHME CORP.]	24

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dulera	MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE	Organon LLC	8f399784-f257-4f31-b3dc-368bf2a1864d	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022518 application number: NDA022518

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04201GDN4R	MOMETASONE FUROATE	83919-23-7	MOMETASONE FUROATE
W34SHF8J2K	FORMOTEROL FUMARATE	183814-30-4	FORMOTEROL FUMARATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0085-4610-01	00085461001	1 CANISTER in 1 CARTON (0085-4610-01) > 120 AEROSOL in 1 CANISTER	1 canister	2010-06-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dulera - Merck Sharp & Dohme Corp.	Merck Sharp & Dohme Corp.	2020-12-04	HUMAN PRESCRIPTION DRUG LABEL	41
Dulera - A-S Medication Solutions	A-S Medication Solutions	2017-12-13	HUMAN PRESCRIPTION DRUG LABEL	4