NDC 0781-3442

SYMJEPI

Epinephrine

SYMJEPI is a Intramuscular; Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc.. The primary component is Epinephrine.

• Product ID: 0781-3442_4f7b9e37-f25a-42d6-81ab-e5fdd973ca99
• NDC: 0781-3442
• Product Type: Human Prescription Drug
• Proprietary Name: SYMJEPI
• Generic Name: Epinephrine
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR; SUBCUTANEOUS
• Marketing Start Date: 2018-12-07
• Marketing Category: NDA / NDA
• Application Number: NDA207534
• Labeler Name: Sandoz 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: 2020-12-31

Packaging

NDC 0781-3442-20

2 SYRINGE in 1 CARTON (0781-3442-20) > .3 mL in 1 SYRINGE

• Marketing Start Date: 2018-12-07
• Marketing End Date: 2021-07-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0781-3442-20 [00781344220]

SYMJEPI INJECTION

• Marketing Category: NDA
• Application Number: NDA207534
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-12-07

NDC 0781-3442-10 [00781344210]

SYMJEPI INJECTION

• Marketing Category: NDA
• Application Number: NDA207534
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-12-07

Drug Details

Active Ingredients

Ingredient	Strength
EPINEPHRINE	.3 mg/.3mL

OpenFDA Data

• SPL SET ID: b1c6a201-4f23-489f-9fca-f8c82bb9fa58
• Manufacturer:
  • Sandoz Inc.
• UNII:
  • YKH834O4BH
• RxNorm Concept Unique ID - RxCUI:
  • 1989117
  • 1989112

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 "SYMJEPI" or generic name "Epinephrine"

NDC	Brand Name	Generic Name
0781-3442	SYMJEPI	Epinephrine
0781-3448	SYMJEPI	Epinephrine
38739-200	SYMJEPI	SYMJEPI
78670-131	Symjepi	Symjepi
78670-130	Symjepi	Symjepi
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