epipen

Generic: epinephrine

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name epipen
Generic Name epinephrine
Labeler viatris specialty llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

epinephrine .3 mg/.3mL

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 49502-500
Product ID 49502-500_81569d26-e9b3-4c1d-ac34-8a4cf5b4a98b
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 49502500
Hyphenated Format 49502-500

Supplemental Identifiers

RxCUI
727316 727347 727386 1870207
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 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 (49502-500-02) / 1 SYRINGE, GLASS in 1 CONTAINER (49502-500-01) / .3 mL in 1 SYRINGE, GLASS
  • 2 CONTAINER in 1 CARTON (49502-500-92) / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS
source: ndc

Packages (2)

49502-500-02 2 CONTAINER in 1 CARTON (49502-500-02) / 1 SYRINGE, GLASS in 1 CONTAINER (49502-500-01) / .3 mL in 1 SYRINGE, GLASS 49502-500-92 2 CONTAINER in 1 CARTON (49502-500-92) / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS

Ingredients (1)

epinephrine (.3 mg/.3mL)

Linked Drug Pages (1)

EPIPEN, EPIPEN JR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "81569d26-e9b3-4c1d-ac34-8a4cf5b4a98b", "openfda": {"nui": ["N0000000209", "N0000000245", "N0000175552", "N0000175555", "N0000175570", "M0003647"], "unii": ["YKH834O4BH"], "rxcui": ["727316", "727347", "727386", "1870207"], "spl_set_id": ["7560c201-9246-487c-a13b-6295db04274a"], "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": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 CONTAINER in 1 CARTON (49502-500-02)  / 1 SYRINGE, GLASS in 1 CONTAINER (49502-500-01)  / .3 mL in 1 SYRINGE, GLASS", "package_ndc": "49502-500-02", "marketing_start_date": "19871222"}, {"sample": true, "description": "2 CONTAINER in 1 CARTON (49502-500-92)  / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS", "package_ndc": "49502-500-92", "marketing_start_date": "19871222"}], "brand_name": "EPIPEN", "product_id": "49502-500_81569d26-e9b3-4c1d-ac34-8a4cf5b4a98b", "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": "49502-500", "generic_name": "epinephrine", "labeler_name": "Viatris Specialty LLC", "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"}