epinephrine

Generic: epinephrine

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name epinephrine
Generic Name epinephrine
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

epinephrine 1 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-698
Product ID 63323-698_4f83895f-638c-4515-af03-7c41ae60a42e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215425
Listing Expiration 2026-12-31
Marketing Start 2025-03-13

Pharmacologic Class

Established (EPC)
alpha-adrenergic agonist [epc] beta-adrenergic agonist [epc] catecholamine [epc]
Mechanism of Action
adrenergic alpha-agonists [moa] adrenergic beta-agonists [moa]
Chemical Structure
catecholamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323698
Hyphenated Format 63323-698

Supplemental Identifiers

RxCUI
310132
UPC
0363323698300
UNII
YKH834O4BH
NUI
N0000000209 N0000000245 N0000175552 N0000175555 N0000175570 M0003647

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name epinephrine (source: ndc)
Generic Name epinephrine (source: ndc)
Application Number NDA215425 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (63323-698-30) / 30 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

63323-698-30 1 VIAL, MULTI-DOSE in 1 CARTON (63323-698-30) / 30 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

epinephrine (1 mg/mL)

Linked Drug Pages (1)

EPINEPHRINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "4f83895f-638c-4515-af03-7c41ae60a42e", "openfda": {"nui": ["N0000000209", "N0000000245", "N0000175552", "N0000175555", "N0000175570", "M0003647"], "upc": ["0363323698300"], "unii": ["YKH834O4BH"], "rxcui": ["310132"], "spl_set_id": ["4f83895f-638c-4515-af03-7c41ae60a42e"], "pharm_class_cs": ["Catecholamines [CS]"], "pharm_class_epc": ["alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Agonist [EPC]", "Catecholamine [EPC]"], "pharm_class_moa": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Agonists [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (63323-698-30)  / 30 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "63323-698-30", "marketing_start_date": "20250313"}], "brand_name": "EPINEPHRINE", "product_id": "63323-698_4f83895f-638c-4515-af03-7c41ae60a42e", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Agonists [MoA]", "Catecholamine [EPC]", "Catecholamines [CS]", "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Agonist [EPC]"], "product_ndc": "63323-698", "generic_name": "EPINEPHRINE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EPINEPHRINE", "active_ingredients": [{"name": "EPINEPHRINE", "strength": "1 mg/mL"}], "application_number": "NDA215425", "marketing_category": "NDA", "marketing_start_date": "20250313", "listing_expiration_date": "20261231"}