epipen

Generic: epinephrine

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name epipen
Generic Name epinephrine
Labeler asclemed usa, inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

epinephrine .3 mg/.3mL

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-584
Product ID 76420-584_040d1b88-235a-aa09-e063-6394a90adbad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019430
Listing Expiration 2026-12-31
Marketing Start 1987-12-22

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 76420584
Hyphenated Format 76420-584

Supplemental Identifiers

RxCUI
727347 1870207
UNII
YKH834O4BH
NUI
N0000000209 N0000000245 N0000175552 N0000175555 N0000175570 M0003647

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 epipen (source: ndc)
Generic Name epinephrine (source: ndc)
Application Number NDA019430 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • .3 mg/.3mL
source: ndc
Packaging
  • 2 CONTAINER in 1 CARTON (76420-584-02) / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

76420-584-02 2 CONTAINER in 1 CARTON (76420-584-02) / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS

Ingredients (1)

epinephrine (.3 mg/.3mL)

Linked Drug Pages (1)

EPIPEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "040d1b88-235a-aa09-e063-6394a90adbad", "openfda": {"nui": ["N0000000209", "N0000000245", "N0000175552", "N0000175555", "N0000175570", "M0003647"], "unii": ["YKH834O4BH"], "rxcui": ["727347", "1870207"], "spl_set_id": ["311af6d9-20c0-4b87-b236-4185bfa49988"], "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": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "2 CONTAINER in 1 CARTON (76420-584-02)  / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS", "package_ndc": "76420-584-02", "marketing_start_date": "20230829"}], "brand_name": "EPIPEN", "product_id": "76420-584_040d1b88-235a-aa09-e063-6394a90adbad", "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": "76420-584", "generic_name": "epinephrine", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EPIPEN", "active_ingredients": [{"name": "EPINEPHRINE", "strength": ".3 mg/.3mL"}], "application_number": "NDA019430", "marketing_category": "NDA", "marketing_start_date": "19871222", "listing_expiration_date": "20261231"}