ammonia n 13

Generic: nh3n13

Labeler: the feinstein institutes for medical research
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ammonia n 13
Generic Name nh3n13
Labeler the feinstein institutes for medical research
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

ammonia n-13 37.5 mCi/mL

Manufacturer
THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH

Identifiers & Regulatory

Product NDC 13267-456
Product ID 13267-456_0bd46b33-99e9-4989-8816-182d7d72babb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022119
Listing Expiration 2026-12-31
Marketing Start 2007-08-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13267456
Hyphenated Format 13267-456

Supplemental Identifiers

UNII
9OQO0E343Z
NUI
N0000177914 N0000000205

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 ammonia n 13 (source: ndc)
Generic Name nh3n13 (source: ndc)
Application Number NDA022119 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 37.5 mCi/mL
source: ndc
Packaging
  • 8 mL in 1 VIAL, GLASS (13267-456-56)
source: ndc

Packages (1)

13267-456-56 8 mL in 1 VIAL, GLASS (13267-456-56)

Ingredients (1)

ammonia n-13 (37.5 mCi/mL)

Linked Drug Pages (1)

Ammonia N 13 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "0bd46b33-99e9-4989-8816-182d7d72babb", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["9OQO0E343Z"], "spl_set_id": ["c857724f-b172-4844-ad42-6fa4c42b0405"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 mL in 1 VIAL, GLASS (13267-456-56)", "package_ndc": "13267-456-56", "marketing_start_date": "20070823"}], "brand_name": "Ammonia N 13", "product_id": "13267-456_0bd46b33-99e9-4989-8816-182d7d72babb", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "13267-456", "generic_name": "NH3N13", "labeler_name": "THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ammonia N 13", "active_ingredients": [{"name": "AMMONIA N-13", "strength": "37.5 mCi/mL"}], "application_number": "NDA022119", "marketing_category": "NDA", "marketing_start_date": "20070823", "listing_expiration_date": "20261231"}