EPIPEN

Product NDC: 49502-500
11-digit product format: 495020500
Labeler code: 49502
Product ID: 49502-500_81569d26-e9b3-4c1d-ac34-8a4cf5b4a98b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: epinephrine
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: Viatris Specialty LLC
Application: NDA019430
Marketing category: NDA
Marketing start: 1987-12-22
Substance: EPINEPHRINE
Active strength: .3 mg/.3mL
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: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: EPIPEN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EPINEPHRINE	.3 mg/.3mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	YKH834O4BH
Rxcui	727316, 727347, 727386, 1870207

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
f7046b89-2016-499a-adc6-78479172abc6	Product name	1	20230425
2686d634-e712-4007-8dbf-3d37c6c4d71f	Product name	1	20181121
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49502-500-01	EPIPEN	0.3 mL in 1 SYRINGE, GLASS	INJECTION	0.3	37
49502-500-01	EPIPEN	1 in 1 CONTAINER	INJECTION	1	37
49502-500-02	EPIPEN	2 in 1 CARTON	INJECTION	2	37
49502-500-92	EPIPEN	2 in 1 CARTON	INJECTION	2	37
49502-500-92	EPIPEN	1 in 1 CONTAINER	INJECTION	1	37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49502-500-01	EA - Each	49502-500	b7a3a225-9ccd-4d53-a858-8a284a69d257	1	2022-09-12
49502-500-02	EA - Each	49502-500	942cabcc-475f-4c52-a017-9960981c7d24	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
EPINEPHRINE	ACTIVE INGREDIENT	YKH834O4BH	EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [MYLAN SPECIALTY L.P.]	13
EPINEPHRINE	ACTIVE MOIETY	YKH834O4BH	EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [MYLAN SPECIALTY L.P.]	13
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [MYLAN SPECIALTY L.P.]	13
NITROGEN	INACTIVE INGREDIENT	N762921K75	EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [MYLAN SPECIALTY L.P.]	13
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [MYLAN SPECIALTY L.P.]	13
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [MYLAN SPECIALTY L.P.]	13
WATER	INACTIVE INGREDIENT	059QF0KO0R	EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [MYLAN SPECIALTY L.P.]	13
EPINEPHRINE	ACTIVE INGREDIENT	YKH834O4BH	EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [TYA PHARMACEUTICALS]	4
EPINEPHRINE	ACTIVE MOIETY	YKH834O4BH	EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [TYA PHARMACEUTICALS]	4
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [TYA PHARMACEUTICALS]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [TYA PHARMACEUTICALS]	4
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [TYA PHARMACEUTICALS]	4
Epinephrine	ACTIVE INGREDIENT	YKH834O4BH	EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]	2
EPINEPHRINE	ACTIVE INGREDIENT	YKH834O4BH	EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [PHYSICIANS TOTAL CARE, INC.]	2
Epinephrine	ACTIVE MOIETY	YKH834O4BH	EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]	2
EPINEPHRINE	ACTIVE MOIETY	YKH834O4BH	EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [PHYSICIANS TOTAL CARE, INC.]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [PHYSICIANS TOTAL CARE, INC.]	2
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]	2
Nitrogen	INACTIVE INGREDIENT	N762921K75	EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]	2
NITROGEN	INACTIVE INGREDIENT	N762921K75	EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [PHYSICIANS TOTAL CARE, INC.]	2
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]	2
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [PHYSICIANS TOTAL CARE, INC.]	2
Sodium Metabisulfite	INACTIVE INGREDIENT	4VON5FNS3C	EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [PHYSICIANS TOTAL CARE, INC.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49502-500	EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [VIATRIS SPECIALTY LLC]	37	Current NDC, Legacy NDC, 5 package rows	20250212_7560c201-9246-487c-a13b-6295db04274a.zip

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
727316	EPINEPHrine (generic for EpiPen Jr) 0.15 MG in 0.3 ML Auto-Injector	PSN	7560c201-9246-487c-a13b-6295db04274a	37
1870207	EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-Injector	PSN	7560c201-9246-487c-a13b-6295db04274a	37
727347	EpiPen 0.3 MG in 0.3 ML Auto-Injector	PSN	7560c201-9246-487c-a13b-6295db04274a	37
727386	EpiPen Jr 0.15 MG in 0.3 ML Auto-Injector	PSN	7560c201-9246-487c-a13b-6295db04274a	37
727386	NDA019430 0.3 ML epinephrine 0.5 MG/ML Auto-Injector [Epipen]	SBD	7560c201-9246-487c-a13b-6295db04274a	37
727347	NDA019430 0.3 ML epinephrine 1 MG/ML Auto-Injector [Epipen]	SBD	7560c201-9246-487c-a13b-6295db04274a	37
727316	NDA019430 0.3 ML epinephrine 0.5 MG/ML Auto-Injector	SCD	7560c201-9246-487c-a13b-6295db04274a	37
1870207	NDA019430 0.3 ML epinephrine 1 MG/ML Auto-Injector	SCD	7560c201-9246-487c-a13b-6295db04274a	37
727347	0.3 ML Epipen 1 MG/ML Auto-Injector	SY	7560c201-9246-487c-a13b-6295db04274a	37
727316	epinephrine (generic for EpiPen Jr) 0.15 MG per 0.3 ML Auto-Injector	SY	7560c201-9246-487c-a13b-6295db04274a	37
1870207	epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-Injector	SY	7560c201-9246-487c-a13b-6295db04274a	37
727347	Epipen 0.3 MG per 0.3 ML Auto-Injector	SY	7560c201-9246-487c-a13b-6295db04274a	37
727386	Epipen Jr 0.15 MG per 0.3 ML Auto-Injector	SY	7560c201-9246-487c-a13b-6295db04274a	37
727386	NDA019430 0.3 ML Epipen 0.5 MG/ML Auto-Injector	SY	7560c201-9246-487c-a13b-6295db04274a	37
727347	NDA019430 0.3 ML Epipen 1 MG/ML Auto-Injector	SY	7560c201-9246-487c-a13b-6295db04274a	37
727316	EPINEPHrine (generic for EpiPen Jr) 0.15 MG in 0.3 ML Auto-Injector	PSN	75e96faa-545b-52d6-e053-2991aa0a8fb8	4
727316	EPINEPHrine (generic for EpiPen Jr) 0.15 MG in 0.3 ML Auto-Injector	PSN	cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6	4
1870207	EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-Injector	PSN	75e96faa-545b-52d6-e053-2991aa0a8fb8	4
1870207	EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-Injector	PSN	cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6	4
727347	EpiPen 0.3 MG in 0.3 ML Auto-Injector	PSN	cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6	4
727386	EpiPen Jr 0.15 MG in 0.3 ML Auto-Injector	PSN	cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6	4
727386	NDA019430 0.3 ML epinephrine 0.5 MG/ML Auto-Injector [Epipen]	SBD	cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6	4
727347	NDA019430 0.3 ML epinephrine 1 MG/ML Auto-Injector [Epipen]	SBD	cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6	4
727316	NDA019430 0.3 ML epinephrine 0.5 MG/ML Auto-Injector	SCD	75e96faa-545b-52d6-e053-2991aa0a8fb8	4
727316	NDA019430 0.3 ML epinephrine 0.5 MG/ML Auto-Injector	SCD	cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6	4
1870207	NDA019430 0.3 ML epinephrine 1 MG/ML Auto-Injector	SCD	75e96faa-545b-52d6-e053-2991aa0a8fb8	4
1870207	NDA019430 0.3 ML epinephrine 1 MG/ML Auto-Injector	SCD	cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6	4
727347	0.3 ML Epipen 1 MG/ML Auto-Injector	SY	cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6	4
727316	epinephrine (generic for EpiPen Jr) 0.15 MG per 0.3 ML Auto-Injector	SY	75e96faa-545b-52d6-e053-2991aa0a8fb8	4
727316	epinephrine (generic for EpiPen Jr) 0.15 MG per 0.3 ML Auto-Injector	SY	cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6	4
1870207	epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-Injector	SY	75e96faa-545b-52d6-e053-2991aa0a8fb8	4
1870207	epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-Injector	SY	cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6	4
727347	Epipen 0.3 MG per 0.3 ML Auto-Injector	SY	cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6	4
727386	Epipen Jr 0.15 MG per 0.3 ML Auto-Injector	SY	cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6	4
727386	NDA019430 0.3 ML Epipen 0.5 MG/ML Auto-Injector	SY	cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6	4
727347	NDA019430 0.3 ML Epipen 1 MG/ML Auto-Injector	SY	cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6	4
727316	EPINEPHrine (generic for EpiPen Jr) 0.15 MG in 0.3 ML Auto-Injector	PSN	e47dc072-9cab-468e-851c-08c01652f447	2
1870207	EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-Injector	PSN	f3f1a483-e29a-4e3e-b677-16fa87fe5e5a	2
1870207	EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-Injector	PSN	e47dc072-9cab-468e-851c-08c01652f447	2
727347	EpiPen 0.3 MG in 0.3 ML Auto-Injector	PSN	f3f1a483-e29a-4e3e-b677-16fa87fe5e5a	2
727347	EpiPen 0.3 MG in 0.3 ML Auto-Injector	PSN	e47dc072-9cab-468e-851c-08c01652f447	2
727386	EpiPen Jr 0.15 MG in 0.3 ML Auto-Injector	PSN	e47dc072-9cab-468e-851c-08c01652f447	2
727386	NDA019430 0.3 ML epinephrine 0.5 MG/ML Auto-Injector [Epipen]	SBD	e47dc072-9cab-468e-851c-08c01652f447	2
727347	NDA019430 0.3 ML epinephrine 1 MG/ML Auto-Injector [Epipen]	SBD	f3f1a483-e29a-4e3e-b677-16fa87fe5e5a	2
727347	NDA019430 0.3 ML epinephrine 1 MG/ML Auto-Injector [Epipen]	SBD	e47dc072-9cab-468e-851c-08c01652f447	2
727316	NDA019430 0.3 ML epinephrine 0.5 MG/ML Auto-Injector	SCD	e47dc072-9cab-468e-851c-08c01652f447	2
1870207	NDA019430 0.3 ML epinephrine 1 MG/ML Auto-Injector	SCD	e47dc072-9cab-468e-851c-08c01652f447	2
1870207	NDA019430 0.3 ML epinephrine 1 MG/ML Auto-Injector	SCD	f3f1a483-e29a-4e3e-b677-16fa87fe5e5a	2
727347	0.3 ML Epipen 1 MG/ML Auto-Injector	SY	f3f1a483-e29a-4e3e-b677-16fa87fe5e5a	2
727347	0.3 ML Epipen 1 MG/ML Auto-Injector	SY	e47dc072-9cab-468e-851c-08c01652f447	2
727316	epinephrine (generic for EpiPen Jr) 0.15 MG per 0.3 ML Auto-Injector	SY	e47dc072-9cab-468e-851c-08c01652f447	2
1870207	epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-Injector	SY	f3f1a483-e29a-4e3e-b677-16fa87fe5e5a	2
1870207	epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-Injector	SY	e47dc072-9cab-468e-851c-08c01652f447	2
727347	Epipen 0.3 MG per 0.3 ML Auto-Injector	SY	f3f1a483-e29a-4e3e-b677-16fa87fe5e5a	2
727347	Epipen 0.3 MG per 0.3 ML Auto-Injector	SY	e47dc072-9cab-468e-851c-08c01652f447	2
727386	Epipen Jr 0.15 MG per 0.3 ML Auto-Injector	SY	e47dc072-9cab-468e-851c-08c01652f447	2
727386	NDA019430 0.3 ML Epipen 0.5 MG/ML Auto-Injector	SY	e47dc072-9cab-468e-851c-08c01652f447	2
727347	NDA019430 0.3 ML Epipen 1 MG/ML Auto-Injector	SY	f3f1a483-e29a-4e3e-b677-16fa87fe5e5a	2
727347	NDA019430 0.3 ML Epipen 1 MG/ML Auto-Injector	SY	e47dc072-9cab-468e-851c-08c01652f447	2
1870207	EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-Injector	PSN	311af6d9-20c0-4b87-b236-4185bfa49988	1
727347	EpiPen 0.3 MG in 0.3 ML Auto-Injector	PSN	311af6d9-20c0-4b87-b236-4185bfa49988	1
727347	NDA019430 0.3 ML epinephrine 1 MG/ML Auto-Injector [Epipen]	SBD	311af6d9-20c0-4b87-b236-4185bfa49988	1
1870207	NDA019430 0.3 ML epinephrine 1 MG/ML Auto-Injector	SCD	311af6d9-20c0-4b87-b236-4185bfa49988	1
727347	0.3 ML Epipen 1 MG/ML Auto-Injector	SY	311af6d9-20c0-4b87-b236-4185bfa49988	1
1870207	epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-Injector	SY	311af6d9-20c0-4b87-b236-4185bfa49988	1
727347	Epipen 0.3 MG per 0.3 ML Auto-Injector	SY	311af6d9-20c0-4b87-b236-4185bfa49988	1
727347	NDA019430 0.3 ML Epipen 1 MG/ML Auto-Injector	SY	311af6d9-20c0-4b87-b236-4185bfa49988	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49502-500-01	49502050001	0.3 mL in 1 SYRINGE, GLASS	0.3 ml					Historical
49502-500-02	49502050002	2 CONTAINER in 1 CARTON (49502-500-02) / 1 SYRINGE, GLASS in 1 CONTAINER (49502-500-01) / .3 mL in 1 SYRINGE, GLASS	2 container	1987-12-22	0000-00-00	No	No	Current
49502-500-92	49502050092	2 CONTAINER in 1 CARTON (49502-500-92) / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS	2 container	1987-12-22	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EPIPEN	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-08-29	HUMAN PRESCRIPTION DRUG LABEL	1
EPIPEN	Viatris Specialty LLC	2023-02-15	HUMAN PRESCRIPTION DRUG LABEL	37
EPINEPHRINE INJECTION, USP AUTO INJECTOR	HF Acquisition Co LLC, DBA HealthFirst	2022-12-09	HUMAN PRESCRIPTION DRUG LABEL	4
EPIPEN	TYA Pharmaceuticals	2014-05-01	HUMAN PRESCRIPTION DRUG LABEL	4
EpiPen	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-09-25	HUMAN PRESCRIPTION DRUG LABEL	2
EpiPen	Physicians Total Care, Inc.	2012-05-14	HUMAN PRESCRIPTION DRUG LABEL	2

EPIPEN

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#