byetta

Generic: exenatide

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name byetta
Generic Name exenatide
Labeler astrazeneca pharmaceuticals lp
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

exenatide 250 ug/mL

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-6524
Product ID 0310-6524_7333a7dd-9449-4c61-b36d-c5d8d7cc239b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021773
Marketing Start 2014-12-12
Marketing End 2026-11-30

Pharmacologic Class

Established (EPC)
glp-1 receptor agonist [epc]
Mechanism of Action
glucagon-like peptide-1 (glp-1) agonists [moa]
Chemical Structure
glucagon-like peptide 1 [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03106524
Hyphenated Format 0310-6524

Supplemental Identifiers

RxCUI
847910 847913 847915 847917
UNII
9P1872D4OL
NUI
N0000178480 M0160181 N0000020058

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 byetta (source: ndc)
Generic Name exenatide (source: ndc)
Application Number NDA021773 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 250 ug/mL
source: ndc
Packaging
  • 1 CARTRIDGE in 1 CARTON (0310-6524-01) / 2.4 mL in 1 CARTRIDGE
source: ndc

Packages (1)

0310-6524-01 1 CARTRIDGE in 1 CARTON (0310-6524-01) / 2.4 mL in 1 CARTRIDGE

Ingredients (1)

exenatide (250 ug/mL)

Linked Drug Pages (1)

Byetta ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "7333a7dd-9449-4c61-b36d-c5d8d7cc239b", "openfda": {"nui": ["N0000178480", "M0160181", "N0000020058"], "unii": ["9P1872D4OL"], "rxcui": ["847910", "847913", "847915", "847917"], "spl_set_id": ["53d03c03-ebf7-418d-88a8-533eabd2ee4f"], "pharm_class_cs": ["Glucagon-Like Peptide 1 [CS]"], "pharm_class_epc": ["GLP-1 Receptor Agonist [EPC]"], "pharm_class_moa": ["Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CARTRIDGE in 1 CARTON (0310-6524-01)  / 2.4 mL in 1 CARTRIDGE", "package_ndc": "0310-6524-01", "marketing_end_date": "20261130", "marketing_start_date": "20141212"}], "brand_name": "Byetta", "product_id": "0310-6524_7333a7dd-9449-4c61-b36d-c5d8d7cc239b", "dosage_form": "INJECTION", "pharm_class": ["GLP-1 Receptor Agonist [EPC]", "Glucagon-Like Peptide 1 [CS]", "Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]"], "product_ndc": "0310-6524", "generic_name": "exenatide", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Byetta", "active_ingredients": [{"name": "EXENATIDE", "strength": "250 ug/mL"}], "application_number": "NDA021773", "marketing_category": "NDA", "marketing_end_date": "20261130", "marketing_start_date": "20141212"}