epinephrine

Generic: epinephrine

Labeler: bpi labs, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name epinephrine
Generic Name epinephrine
Labeler bpi labs, llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

epinephrine 1 mg/mL

Manufacturer
BPI Labs, LLC

Identifiers & Regulatory

Product NDC 54288-600
Product ID 54288-600_79bfbdaf-2a2d-4b68-8f10-3daf37fdc423
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205029
Listing Expiration 2026-12-31
Marketing Start 2023-01-16

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 54288600
Hyphenated Format 54288-600

Supplemental Identifiers

RxCUI
310132
UPC
0354288600019
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 NDA205029 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (54288-600-01) / 10 mL in 1 VIAL
source: ndc

Packages (1)

54288-600-01 1 VIAL in 1 CARTON (54288-600-01) / 10 mL in 1 VIAL

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": "79bfbdaf-2a2d-4b68-8f10-3daf37fdc423", "openfda": {"nui": ["N0000000209", "N0000000245", "N0000175552", "N0000175555", "N0000175570", "M0003647"], "upc": ["0354288600019"], "unii": ["YKH834O4BH"], "rxcui": ["310132"], "spl_set_id": ["3fd8dd51-0aeb-43dd-9de0-c11b0330b15e"], "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": ["BPI Labs, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (54288-600-01)  / 10 mL in 1 VIAL", "package_ndc": "54288-600-01", "marketing_start_date": "20230116"}], "brand_name": "EPINEPHRINE", "product_id": "54288-600_79bfbdaf-2a2d-4b68-8f10-3daf37fdc423", "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": "54288-600", "generic_name": "EPINEPHRINE", "labeler_name": "BPI Labs, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EPINEPHRINE", "active_ingredients": [{"name": "EPINEPHRINE", "strength": "1 mg/mL"}], "application_number": "NDA205029", "marketing_category": "NDA", "marketing_start_date": "20230116", "listing_expiration_date": "20261231"}