NDC 55045-3207

EpiPen

Epinephrine

EpiPen is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Dispensing Solutions, Inc.. The primary component is Epinephrine.

• Product ID: 55045-3207_f72addbb-85a1-4830-b6db-c2e964b03385
• NDC: 55045-3207
• Product Type: Human Prescription Drug
• Proprietary Name: EpiPen
• Generic Name: Epinephrine
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 1987-12-22
• Marketing Category: NDA / NDA
• Application Number: NDA019430
• Labeler Name: Dispensing Solutions, Inc.
• Substance Name: EPINEPHRINE
• Active Ingredient Strength: 0 mg/.3mL
• Pharm Classes: Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 55045-3207-2

1 CONTAINER in 1 CARTON (55045-3207-2) > 1 SYRINGE, GLASS in 1 CONTAINER > .3 mL in 1 SYRINGE, GLASS

• Marketing Start Date: 1987-12-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55045-3207-2 [55045320702]

EpiPen INJECTION

• Marketing Category: NDA
• Application Number: NDA019430
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1987-12-22
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
EPINEPHRINE	.3 mg/.3mL

OpenFDA Data

• SPL SET ID: f3f1a483-e29a-4e3e-b677-16fa87fe5e5a
• Manufacturer:
  • Dispensing Solutions, Inc.
• UNII:
  • YKH834O4BH
• RxNorm Concept Unique ID - RxCUI:
  • 727347
  • 1870207

Pharmacological Class

• Adrenergic alpha-Agonists [MoA]
• Adrenergic beta-Agonists [MoA]
• alpha-Adrenergic Agonist [EPC]
• beta-Adrenergic Agonist [EPC]
• Catecholamine [EPC]
• Catecholamines [CS]

NDC Crossover Matching brand name "EpiPen" or generic name "Epinephrine"

NDC	Brand Name	Generic Name
70518-1224	EPIPEN	EPIPEN
49502-500	EPIPEN	EPIPEN
55045-3207	EpiPen	EpiPen
64725-0500	EPIPEN	EPIPEN
0220-0076	Adrenalinum	EPINEPHRINE
0220-0078	Adrenalinum	EPINEPHRINE
0093-5985	Epinephrine	Epinephrine
0093-5986	Epinephrine	Epinephrine
0115-1694	epinephrine	epinephrine
0115-1695	epinephrine	epinephrine
0404-9856	Epinephrine	Epinephrine
0404-9857	EPINEPHRINE	EPINEPHRINE
0409-4921	Epinephrine	EPINEPHRINE
0409-4933	EPINEPHRINE	epinephrine
0409-7241	EPINEPHRINE	epinephrine
0517-1130	Epinephrine	Epinephrine
0517-1171	epinephrine	epinephrine
0781-3442	SYMJEPI	Epinephrine
0781-3448	SYMJEPI	Epinephrine