cerianna

Generic: fluoroestradiol f 18

Labeler: ge healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cerianna
Generic Name fluoroestradiol f 18
Labeler ge healthcare inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

fluoroestradiol f-18 100 mCi/mL

Manufacturer
GE Healthcare Inc.

Identifiers & Regulatory

Product NDC 72874-001
Product ID 72874-001_8a7a4aba-3d6c-467c-a033-a9df0b92bf6e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212155
Listing Expiration 2027-12-31
Marketing Start 2020-05-20

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 72874001
Hyphenated Format 72874-001

Supplemental Identifiers

UNII
T32277KB09
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 cerianna (source: ndc)
Generic Name fluoroestradiol f 18 (source: ndc)
Application Number NDA212155 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mCi/mL
source: ndc
Packaging
  • 50 mL in 1 VIAL, MULTI-DOSE (72874-001-01)
source: ndc

Packages (1)

72874-001-01 50 mL in 1 VIAL, MULTI-DOSE (72874-001-01)

Ingredients (1)

fluoroestradiol f-18 (100 mCi/mL)

Linked Drug Pages (1)

CERIANNA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "8a7a4aba-3d6c-467c-a033-a9df0b92bf6e", "openfda": {"nui": ["N0000177914", "N0000175869"], "unii": ["T32277KB09"], "spl_set_id": ["b2c2a2df-cf3e-4a29-a033-231ed5a94b58"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Positron Emitting Activity [MoA]"], "manufacturer_name": ["GE Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 VIAL, MULTI-DOSE (72874-001-01)", "package_ndc": "72874-001-01", "marketing_start_date": "20200520"}], "brand_name": "CERIANNA", "product_id": "72874-001_8a7a4aba-3d6c-467c-a033-a9df0b92bf6e", "dosage_form": "INJECTION", "pharm_class": ["Positron Emitting Activity [MoA]", "Radioactive Diagnostic Agent [EPC]"], "product_ndc": "72874-001", "generic_name": "FLUOROESTRADIOL F 18", "labeler_name": "GE Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CERIANNA", "active_ingredients": [{"name": "FLUOROESTRADIOL F-18", "strength": "100 mCi/mL"}], "application_number": "NDA212155", "marketing_category": "NDA", "marketing_start_date": "20200520", "listing_expiration_date": "20271231"}