neffy

Product NDC: 85766-130
11-digit product format: 857660130
Labeler code: 85766
Product ID: 85766-130_50325060-a6dc-c9ae-e063-6294a90a5a34
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: epinephrine
Dosage form: SPRAY
Route: NASAL
Labeler: Sportpharm LLC
Application: NDA214697
Marketing category: NDA
Marketing start: 2024-08-09
Substance: EPINEPHRINE
Active strength: 2 mg/100uL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214697-001	NEFFY	EPINEPHRINE	2MG/SPRAY	SPRAY / NASAL		RLD, RS	2024-08-09
N214697-002	NEFFY	EPINEPHRINE	1MG/SPRAY	SPRAY / NASAL		RLD, RS	2025-03-05

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214697-001	10576156	2038-02-06		Drug product	2024-08-28
N214697-001	11173209	2038-02-06	U-3979		2024-08-28
N214697-001	10682414	2039-02-06	U-3979		2024-08-28
N214697-001	11191838	2039-02-06	U-3979	Drug product	2024-08-28
N214697-001	11717571	2039-02-06	U-3979		2024-08-28
N214697-001	11744895	2039-02-06	U-3979		2024-08-28
N214697-001	11918655	2039-02-06	U-3979	Drug product	2024-08-28
N214697-001	12324838	2039-02-06		Drug product	2025-06-20
N214697-002	10576156	2038-02-06		Drug product	2025-04-03
N214697-002	11173209	2038-02-06	U-3979		2025-04-03
N214697-002	10682414	2039-02-06	U-3979		2025-04-03
N214697-002	11191838	2039-02-06	U-3979	Drug product	2025-04-03
N214697-002	11717571	2039-02-06	U-3979		2025-04-03
N214697-002	11744895	2039-02-06	U-3979		2025-04-03
N214697-002	11918655	2039-02-06	U-3979		2025-04-03
N214697-002	12324838	2039-02-06		Drug product	2025-06-20

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-002	NEFFY	1MG/SPRAY	SPRAY / NASAL	RLD, RS	2025-03-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-002	NEFFY	1MG/SPRAY	SPRAY / NASAL	RLD, RS	2025-03-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214697-002	NEFFY	1MG/SPRAY	SPRAY / NASAL	RLD, RS	2025-03-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214697-002	NEFFY	1MG/SPRAY	SPRAY / NASAL	RLD, RS	2025-03-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214697-002	NEFFY	1MG/SPRAY	SPRAY / NASAL	RLD, RS	2025-03-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214697-002	NEFFY	1MG/SPRAY	SPRAY / NASAL	RLD, RS	2025-03-05	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 145 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N214697-001	10576156	2038-02-06		Drug product	2024-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-001	11173209	2038-02-06	U-3979		2024-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-001	10682414	2039-02-06	U-3979		2024-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-001	11191838	2039-02-06	U-3979	Drug product	2024-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-001	11717571	2039-02-06	U-3979		2024-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-001	11744895	2039-02-06	U-3979		2024-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-001	11918655	2039-02-06	U-3979	Drug product	2024-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-001	12324838	2039-02-06		Drug product	2025-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-002	10576156	2038-02-06		Drug product	2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-002	11173209	2038-02-06	U-3979		2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-002	10682414	2039-02-06	U-3979		2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-002	11191838	2039-02-06	U-3979	Drug product	2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-002	11717571	2039-02-06	U-3979		2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-002	11744895	2039-02-06	U-3979		2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-002	11918655	2039-02-06	U-3979		2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-002	12324838	2039-02-06		Drug product	2025-06-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214697-001	10576156	2038-02-06		Drug product	2024-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-001	11173209	2038-02-06	U-3979		2024-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-001	10682414	2039-02-06	U-3979		2024-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-001	11191838	2039-02-06	U-3979	Drug product	2024-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-001	11717571	2039-02-06	U-3979		2024-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-001	11744895	2039-02-06	U-3979		2024-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-001	11918655	2039-02-06	U-3979	Drug product	2024-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-001	12324838	2039-02-06		Drug product	2025-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-002	10576156	2038-02-06		Drug product	2025-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-002	11173209	2038-02-06	U-3979		2025-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-002	10682414	2039-02-06	U-3979		2025-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-002	11191838	2039-02-06	U-3979	Drug product	2025-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-002	11717571	2039-02-06	U-3979		2025-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-002	11744895	2039-02-06	U-3979		2025-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-002	11918655	2039-02-06	U-3979		2025-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-002	12324838	2039-02-06		Drug product	2025-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214697-001	10576156	2038-02-06		Drug product	2024-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214697-001	11173209	2038-02-06	U-3979		2024-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214697-001	10682414	2039-02-06	U-3979		2024-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214697-001	11191838	2039-02-06	U-3979	Drug product	2024-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214697-001	11717571	2039-02-06	U-3979		2024-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214697-001	11744895	2039-02-06	U-3979		2024-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214697-001	11918655	2039-02-06	U-3979	Drug product	2024-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214697-001	12324838	2039-02-06		Drug product	2025-06-20	`011fe1cb6892…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EPINEPHRINE	2 mg/100uL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YKH834O4BH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2693442	Internal RxNorm lookup
2693448	Internal RxNorm lookup
2709207	Internal RxNorm lookup
2709209	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
2052f9db-7d76-443b-b702-b6b499f9a4b8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0b4ec9ca-d305-43fc-88dd-7a510313efe0	Product name	1	20260105
bb209f42-a85f-4fee-9d3d-c9dded168625	Product name	1	20251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3	Product name	3	20251118
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
b5b1095b-40cd-8a9e-b111-502545045b07	Product name	4	20250325
e190029e-423b-473c-8e04-2ada59b5b711	Product name	1	20250314
e0031c74-3853-42bc-8e10-86dbbe83992e	Product name	2	20231116
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
f7046b89-2016-499a-adc6-78479172abc6	Product name	1	20230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
2686d634-e712-4007-8dbf-3d37c6c4d71f	Product name	1	20181121
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42	Product name	1	20180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303a	Product name	1	20170815
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85766-130-02	neffy	1 in 1 BLISTER PACK	SPRAY	1		2
85766-130-02	neffy	2 in 1 CARTON	SPRAY	2		2

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
neffy	EPINEPHRINE	Sportpharm LLC	2052f9db-7d76-443b-b702-b6b499f9a4b8	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214697 application number: NDA214697 ndc (product): 85766-130
neffy	EPINEPHRINE	ARS Pharmaceuticals Operations, Inc.	a1758142-a905-401d-8961-05829f51023a	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214697 application number: NDA214697
neffy	EPINEPHRINE	Medical Purchasing Solutions, LLC	2d4063e8-f56c-6902-e063-6294a90a0d40	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214697 application number: NDA214697

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YKH834O4BH	EPINEPHRINE	51-43-4	EPINEPHRINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2709207	EPINEPHrine 1 MG in 0.1 ML Nasal Spray	PSN	2052f9db-7d76-443b-b702-b6b499f9a4b8	2
2693442	EPINEPHrine 2 MG in 0.1 ML Nasal Spray	PSN	2052f9db-7d76-443b-b702-b6b499f9a4b8	2
2709209	neffy 1 MG in 0.1 ML Nasal Spray	PSN	2052f9db-7d76-443b-b702-b6b499f9a4b8	2
2693448	neffy 2 MG in 0.1 ML Nasal Spray	PSN	2052f9db-7d76-443b-b702-b6b499f9a4b8	2
2709209	epinephrine 10 MG/ML Nasal Spray [Neffy]	SBD	2052f9db-7d76-443b-b702-b6b499f9a4b8	2
2693448	epinephrine 20 MG/ML Nasal Spray [Neffy]	SBD	2052f9db-7d76-443b-b702-b6b499f9a4b8	2
2709207	epinephrine 10 MG/ML Nasal Spray	SCD	2052f9db-7d76-443b-b702-b6b499f9a4b8	2
2693442	epinephrine 20 MG/ML Nasal Spray	SCD	2052f9db-7d76-443b-b702-b6b499f9a4b8	2
2709207	epinephrine 1 MG per 0.1 ML Nasal Spray	SY	2052f9db-7d76-443b-b702-b6b499f9a4b8	2
2693442	epinephrine 2 MG per 0.1 ML Nasal Spray	SY	2052f9db-7d76-443b-b702-b6b499f9a4b8	2
2709209	Neffy 1 MG per 0.1 ML Nasal Spray	SY	2052f9db-7d76-443b-b702-b6b499f9a4b8	2
2709209	Neffy 10 MG/ML Nasal Spray	SY	2052f9db-7d76-443b-b702-b6b499f9a4b8	2
2693448	Neffy 2 MG per 0.1 ML Nasal Spray	SY	2052f9db-7d76-443b-b702-b6b499f9a4b8	2
2693448	Neffy 20 MG/ML Nasal Spray	SY	2052f9db-7d76-443b-b702-b6b499f9a4b8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85766-130-02	85766013002	2 BLISTER PACK in 1 CARTON (85766-130-02) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / 100 uL in 1 VIAL, SINGLE-DOSE	2 blister pack	2025-12-06	No	No	Current