epinephrine

Generic: epinephrine

Labeler: amneal pharmaceuticals private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name epinephrine
Generic Name epinephrine
Labeler amneal pharmaceuticals private limited
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

epinephrine 1 mg/mL

Manufacturer
Amneal Pharmaceuticals Private Limited

Identifiers & Regulatory

Product NDC 80830-1659
Product ID 80830-1659_fed06ffc-e17e-4809-ad5f-92e1a815c0aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218208
Listing Expiration 2026-12-31
Marketing Start 2025-12-08

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 808301659
Hyphenated Format 80830-1659

Supplemental Identifiers

RxCUI
1660014
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 ANDA218208 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 25 VIAL, GLASS in 1 CARTON (80830-1659-2) / 1 mL in 1 VIAL, GLASS (80830-1659-1)
source: ndc

Packages (1)

80830-1659-2 25 VIAL, GLASS in 1 CARTON (80830-1659-2) / 1 mL in 1 VIAL, GLASS (80830-1659-1)

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": "fed06ffc-e17e-4809-ad5f-92e1a815c0aa", "openfda": {"nui": ["N0000000209", "N0000000245", "N0000175552", "N0000175555", "N0000175570", "M0003647"], "unii": ["YKH834O4BH"], "rxcui": ["1660014"], "spl_set_id": ["33fa2443-5c80-4967-98bb-f60d3144421c"], "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": ["Amneal Pharmaceuticals Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, GLASS in 1 CARTON (80830-1659-2)  / 1 mL in 1 VIAL, GLASS (80830-1659-1)", "package_ndc": "80830-1659-2", "marketing_start_date": "20251208"}], "brand_name": "EPINEPHRINE", "product_id": "80830-1659_fed06ffc-e17e-4809-ad5f-92e1a815c0aa", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Agonists [MoA]", "Catecholamine [EPC]", "Catecholamines [CS]", "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Agonist [EPC]"], "product_ndc": "80830-1659", "generic_name": "epinephrine", "labeler_name": "Amneal Pharmaceuticals Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EPINEPHRINE", "active_ingredients": [{"name": "EPINEPHRINE", "strength": "1 mg/mL"}], "application_number": "ANDA218208", "marketing_category": "ANDA", "marketing_start_date": "20251208", "listing_expiration_date": "20261231"}