ammonia n 13

Generic: ammonia n-13

Labeler: ionetix corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ammonia n 13
Generic Name ammonia n-13
Labeler ionetix corporation
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

ammonia n-13 37.5 mCi/mL

Manufacturer
Ionetix Corporation

Identifiers & Regulatory

Product NDC 71162-001
Product ID 71162-001_36b0308e-2204-31d0-e063-6394a90a4578
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210524
Listing Expiration 2026-12-31
Marketing Start 2018-12-21

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 71162001
Hyphenated Format 71162-001

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 ammonia n-13 (source: ndc)
Application Number ANDA210524 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 37.5 mCi/mL
source: ndc
Packaging
  • 5 mL in 1 SYRINGE, PLASTIC (71162-001-05)
  • 1 VIAL, GLASS in 1 CONTAINER (71162-001-10) / 10 mL in 1 VIAL, GLASS
source: ndc

Packages (2)

71162-001-05 5 mL in 1 SYRINGE, PLASTIC (71162-001-05) 71162-001-10 1 VIAL, GLASS in 1 CONTAINER (71162-001-10) / 10 mL in 1 VIAL, GLASS

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": "36b0308e-2204-31d0-e063-6394a90a4578", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["9OQO0E343Z"], "spl_set_id": ["61e196ba-3812-4ffd-8032-12b215378fef"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["Ionetix Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 SYRINGE, PLASTIC (71162-001-05)", "package_ndc": "71162-001-05", "marketing_start_date": "20200131"}, {"sample": false, "description": "1 VIAL, GLASS in 1 CONTAINER (71162-001-10)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "71162-001-10", "marketing_start_date": "20181221"}], "brand_name": "Ammonia N 13", "product_id": "71162-001_36b0308e-2204-31d0-e063-6394a90a4578", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "71162-001", "generic_name": "Ammonia N-13", "labeler_name": "Ionetix Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ammonia N 13", "active_ingredients": [{"name": "AMMONIA N-13", "strength": "37.5 mCi/mL"}], "application_number": "ANDA210524", "marketing_category": "ANDA", "marketing_start_date": "20181221", "listing_expiration_date": "20261231"}