NDC 70518-1224

EPIPEN

Epinephrine

EPIPEN is a Intramuscular Injection in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Epinephrine.

• Product ID: 70518-1224_6dd7bb3c-6f56-7763-e053-2991aa0a5b0e
• NDC: 70518-1224
• Product Type: Human Prescription Drug
• Proprietary Name: EPIPEN
• Generic Name: Epinephrine
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2018-05-25
• Marketing Category: NDA / NDA
• Application Number: NDA019430
• Labeler Name: REMEDYREPACK 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: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 70518-1224-0

2 CONTAINER in 1 CARTON (70518-1224-0) > 1 SYRINGE, GLASS in 1 CONTAINER > .3 mL in 1 SYRINGE, GLASS

• Marketing Start Date: 2018-05-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-1224-0 [70518122400]

EPIPEN INJECTION

• Marketing Category: NDA
• Application Number: NDA019430
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-05-25
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
EPINEPHRINE	.3 mg/.3mL

OpenFDA Data

• SPL SET ID: 6ee4fecf-83b1-46f9-9b40-f8594710d2f5
• Manufacturer:
  • REMEDYREPACK 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