ammonia n 13

Generic: ammonia n-13

Labeler: mayo clinic
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ammonia n 13
Generic Name ammonia n-13
Labeler mayo clinic
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ammonia n-13 37.5 mCi/mL

Manufacturer
Mayo Clinic

Identifiers & Regulatory

Product NDC 52670-552
Product ID 52670-552_46dfe34a-40c9-373e-e063-6294a90af7cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203321
Listing Expiration 2026-12-31
Marketing Start 2013-02-25

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 52670552
Hyphenated Format 52670-552

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 ANDA203321 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 37.5 mCi/mL
source: ndc
Packaging
  • 30 mL in 1 VIAL, SINGLE-DOSE (52670-552-30)
source: ndc

Packages (1)

52670-552-30 30 mL in 1 VIAL, SINGLE-DOSE (52670-552-30)

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": "46dfe34a-40c9-373e-e063-6294a90af7cf", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["9OQO0E343Z"], "spl_set_id": ["af70d0da-1c2d-44e4-b4cd-7cce6636c7b9"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["Mayo Clinic"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 VIAL, SINGLE-DOSE (52670-552-30)", "package_ndc": "52670-552-30", "marketing_start_date": "20130225"}], "brand_name": "Ammonia N 13", "product_id": "52670-552_46dfe34a-40c9-373e-e063-6294a90af7cf", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "52670-552", "generic_name": "ammonia n-13", "labeler_name": "Mayo Clinic", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ammonia N 13", "active_ingredients": [{"name": "AMMONIA N-13", "strength": "37.5 mCi/mL"}], "application_number": "ANDA203321", "marketing_category": "ANDA", "marketing_start_date": "20130225", "listing_expiration_date": "20261231"}