amyvid

Generic: florbetapir f 18

Labeler: eli lilly and company
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name amyvid
Generic Name florbetapir f 18
Labeler eli lilly and company
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

florbetapir f-18 51 mCi/mL

Manufacturer
Eli Lilly and Company

Identifiers & Regulatory

Product NDC 0002-1200
Product ID 0002-1200_63e1d0b5-c634-4699-91b2-643a6e765139
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202008
Listing Expiration 2027-12-31
Marketing Start 2012-06-01

Pharmacologic Class

Established (EPC)
radioactive diagnostic agent [epc]
Mechanism of Action
positron emitting activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00021200
Hyphenated Format 0002-1200

Supplemental Identifiers

UNII
6W15Z5R0RU
NUI
N0000177914 N0000175869

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 amyvid (source: ndc)
Generic Name florbetapir f 18 (source: ndc)
Application Number NDA202008 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 51 mCi/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-48) / 100 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-50) / 50 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (2)

Ingredients (1)

florbetapir f-18 (51 mCi/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "63e1d0b5-c634-4699-91b2-643a6e765139", "openfda": {"nui": ["N0000177914", "N0000175869"], "unii": ["6W15Z5R0RU"], "spl_set_id": ["bb5a5043-0f51-11df-8a39-0800200c9a66"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Positron Emitting Activity [MoA]"], "manufacturer_name": ["Eli Lilly and Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-48)  / 100 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0002-1200-48", "marketing_start_date": "20230522"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-50)  / 50 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0002-1200-50", "marketing_start_date": "20120601"}], "brand_name": "Amyvid", "product_id": "0002-1200_63e1d0b5-c634-4699-91b2-643a6e765139", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Positron Emitting Activity [MoA]", "Radioactive Diagnostic Agent [EPC]"], "product_ndc": "0002-1200", "generic_name": "Florbetapir F 18", "labeler_name": "Eli Lilly and Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amyvid", "active_ingredients": [{"name": "FLORBETAPIR F-18", "strength": "51 mCi/mL"}], "application_number": "NDA202008", "marketing_category": "NDA", "marketing_start_date": "20120601", "listing_expiration_date": "20271231"}