Dulera

Product NDC: 78206-127
11-digit product format: 782060127
Labeler code: 78206
Product ID: 78206-127_74079d8a-85a1-4736-8486-76624af02194
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mometasone furoate and formoterol fumarate dihydrate
Dosage form: AEROSOL
Route: RESPIRATORY (INHALATION)
Labeler: Organon LLC
Application: NDA022518
Marketing category: NDA
Marketing start: 2021-06-01
Substance: FORMOTEROL FUMARATE; MOMETASONE FUROATE
Active strength: 5; 100 ug/1; ug/1
Pharmacologic classes: Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	78206-127	78206-127-59	D	Discontinued by firm		2026-08-17

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dulera
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MOMETASONE FUROATE	5 ug/1
FORMOTEROL FUMARATE	100 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W34SHF8J2K	Internal UNII lookup
04201GDN4R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1246308	Internal RxNorm lookup
1246310	Internal RxNorm lookup
1246311	Internal RxNorm lookup
1246313	Internal RxNorm lookup
1660933	Internal RxNorm lookup
1660934	Internal RxNorm lookup
1660937	Internal RxNorm lookup
1660938	Internal RxNorm lookup
2196590	Internal RxNorm lookup
2196592	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
8f399784-f257-4f31-b3dc-368bf2a1864d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0c06c4f4-ea2d-4e6a-a22a-0cf292716367	Product name	4	20250303
9ab9f611-cedd-47ea-a83c-0489c8c04fc6	Product name	1	20231006
a03aea00-1d8b-bfad-a82e-f52f68676f63	Product name	2	20221216
624001e0-0eba-4aac-a60c-c2ecb37d4f08	Product name	1	20220927
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9a	Product name	1	20210204
1cbe9071-502b-482d-9c24-839b43446576	Product name	1	20200123
58f15a44-d9d2-4d61-a39d-7f0223302a8f	Product name	1	20190702
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
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1	Product name	1	20160616
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
78206-127-01	Dulera	1 in 1 CARTON	AEROSOL	1	7
78206-127-01	Dulera	120 in 1 CANISTER	AEROSOL	120	7
78206-127-02	Dulera	60 in 1 CANISTER	AEROSOL	60	7
78206-127-02	Dulera	1 in 1 CARTON	AEROSOL	1	7
78206-127-59	Dulera	1 in 1 CARTON	AEROSOL	1	7
78206-127-59	Dulera	60 in 1 CANISTER	AEROSOL	60	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
78206-127-01	GM - Gram	78206-127	5e552e30-82fb-4a96-a837-9964b8908c9a	1	2021-10-08
78206-127-02	GM - Gram	78206-127	4e2a7e9c-a6ee-4695-8a78-557fea24889f	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78206-127	DULERA (MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE) AEROSOL [ORGANON LLC]	5	Current NDC, Legacy NDC, 6 package rows	20250210_8f399784-f257-4f31-b3dc-368bf2a1864d.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 · 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 ndc (product): 78206-127

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1246310	Dulera 100/5 MCG/INHAL Metered Dose Inhaler, 120 Actuations	PSN	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1660934	Dulera 100/5 MCG/INHAL Metered Dose Inhaler, 60 Actuations	PSN	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1246313	Dulera 200/5 MCG/INHAL Metered Dose Inhaler, 120 Actuations	PSN	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1660938	Dulera 200/5 MCG/INHAL Metered Dose Inhaler, 60 Actuations	PSN	8f399784-f257-4f31-b3dc-368bf2a1864d	7
2196592	Dulera 50/5 MCG/INHAL Metered Dose Inhaler, 120 Actuations	PSN	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1246308	mometasone furoate/formoterol fumarate 100/5 MCG/INHAL Metered Dose Inhaler, 120 Actuations	PSN	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1660933	mometasone furoate/formoterol fumarate 100/5 MCG/INHAL Metered Dose Inhaler, 60 Actuations	PSN	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1246311	mometasone furoate/formoterol fumarate 200/5 MCG/INHAL Metered Dose Inhaler, 120 Actuations	PSN	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1660937	mometasone furoate/formoterol fumarate 200/5 MCG/INHAL Metered Dose Inhaler, 60 Actuations	PSN	8f399784-f257-4f31-b3dc-368bf2a1864d	7
2196590	mometasone furoate/formoterol fumarate 50/5 MCG/INHAL Metered Dose Inhaler, 120 Actuations	PSN	8f399784-f257-4f31-b3dc-368bf2a1864d	7
2196592	120 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.05 MG/ACTUAT Metered Dose Inhaler [Dulera]	SBD	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1246310	120 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.1 MG/ACTUAT Metered Dose Inhaler [Dulera]	SBD	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1246313	120 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.2 MG/ACTUAT Metered Dose Inhaler [Dulera]	SBD	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1660934	60 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.1 MG/ACTUAT Metered Dose Inhaler [Dulera]	SBD	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1660938	60 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.2 MG/ACTUAT Metered Dose Inhaler [Dulera]	SBD	8f399784-f257-4f31-b3dc-368bf2a1864d	7
2196590	120 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.05 MG/ACTUAT Metered Dose Inhaler	SCD	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1246308	120 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.1 MG/ACTUAT Metered Dose Inhaler	SCD	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1246311	120 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.2 MG/ACTUAT Metered Dose Inhaler	SCD	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1660933	60 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.1 MG/ACTUAT Metered Dose Inhaler	SCD	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1660937	60 ACTUAT formoterol fumarate 0.005 MG/ACTUAT / mometasone furoate 0.2 MG/ACTUAT Metered Dose Inhaler	SCD	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1246310	Dulera (mometasone furoate 100 MCG / formoterol fumarate 5 MCG) per ACTUAT Inhalation Aerosol, 120 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1660934	Dulera (mometasone furoate 100 MCG / formoterol fumarate 5 MCG) per ACTUAT Inhalation Aerosol, 60 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1246313	Dulera (mometasone furoate 200 MCG / formoterol fumarate 5 MCG) per ACTUAT Inhalation Aerosol, 120 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1660938	Dulera (mometasone furoate 200 MCG / formoterol fumarate 5 MCG) per ACTUAT Inhalation Aerosol, 60 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
2196592	Dulera (mometasone furoate 50 MCG / formoterol fumarate 5 MCG) per ACTUAT Inhalation Aerosol, 120 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1246310	Dulera 100 mcg/5 mcg per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1660934	Dulera 100 mcg/5 mcg per ACTUAT Metered Dose Inhaler, 60 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1246310	Dulera 100/5 Metered Dose Inhaler, 120 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1660934	Dulera 100/5 Metered Dose Inhaler, 60 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1246313	Dulera 200 mcg/5 mcg per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1660938	Dulera 200 mcg/5 mcg per ACTUAT Metered Dose Inhaler, 60 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1246313	Dulera 200/5 Metered Dose Inhaler, 120 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1660938	Dulera 200/5 Metered Dose Inhaler, 60 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
2196592	Dulera 50 mcg/5 mcg per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
2196592	Dulera 50/5 Metered Dose Inhaler, 120 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1246308	formoterol fumarate 0.005 MG / mometasone furoate 0.1 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1660933	formoterol fumarate 0.005 MG / mometasone furoate 0.1 MG per ACTUAT Metered Dose Inhaler, 60 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1246311	formoterol fumarate 0.005 MG / mometasone furoate 0.2 MG per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1660937	formoterol fumarate 0.005 MG / mometasone furoate 0.2 MG per ACTUAT Metered Dose Inhaler, 60 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1246308	formoterol fumarate 5 MCG / mometasone furoate 100 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1660933	formoterol fumarate 5 MCG / mometasone furoate 100 MCG per ACTUAT Metered Dose Inhaler, 60 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1246311	formoterol fumarate 5 MCG / mometasone furoate 200 MCG per ACTUAT Metered Dose Inhaler, 120 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7
1660937	formoterol fumarate 5 MCG / mometasone furoate 200 MCG per ACTUAT Metered Dose Inhaler, 60 ACTUAT	SY	8f399784-f257-4f31-b3dc-368bf2a1864d	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78206-127-01	78206012701	1 CANISTER in 1 CARTON (78206-127-01) / 120 AEROSOL in 1 CANISTER	1 canister	2021-06-01	0000-00-00	No	No	Current
78206-127-02	78206012702	1 CANISTER in 1 CARTON (78206-127-02) / 60 AEROSOL in 1 CANISTER	1 canister	2021-06-01	0000-00-00	No	No	Current
78206-127-59	78206012759	1 CANISTER in 1 CARTON (78206-127-59) / 60 AEROSOL in 1 CANISTER	1 canister	2021-06-01	0000-00-00	No	No	Current