epinephrine

Generic: epinephrine

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name epinephrine
Generic Name epinephrine
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

epinephrine 1 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-633
Product ID 68083-633_a7f9fba5-54b0-4001-ba9b-86468e159db7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219239
Listing Expiration 2026-12-31
Marketing Start 2025-02-06

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 68083633
Hyphenated Format 68083-633

Supplemental Identifiers

RxCUI
310132
UPC
0368083633011 0368083685010
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 ANDA219239 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (68083-633-01) / 10 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

68083-633-01 1 VIAL, MULTI-DOSE in 1 CARTON (68083-633-01) / 10 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": "a7f9fba5-54b0-4001-ba9b-86468e159db7", "openfda": {"nui": ["N0000000209", "N0000000245", "N0000175552", "N0000175555", "N0000175570", "M0003647"], "upc": ["0368083633011", "0368083685010"], "unii": ["YKH834O4BH"], "rxcui": ["310132"], "spl_set_id": ["79ca73ca-d3c0-40af-9dec-e2f4ce669cda"], "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": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (68083-633-01)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "68083-633-01", "marketing_start_date": "20250206"}], "brand_name": "epinephrine", "product_id": "68083-633_a7f9fba5-54b0-4001-ba9b-86468e159db7", "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": "68083-633", "generic_name": "epinephrine", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "epinephrine", "active_ingredients": [{"name": "EPINEPHRINE", "strength": "1 mg/mL"}], "application_number": "ANDA219239", "marketing_category": "ANDA", "marketing_start_date": "20250206", "listing_expiration_date": "20261231"}