ammonia n 13

Generic: nh3n13

Labeler: the johns hopkins university
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ammonia n 13
Generic Name nh3n13
Labeler the johns hopkins university
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

ammonia n-13 37.5 mCi/mL

Manufacturer
The Johns Hopkins University

Identifiers & Regulatory

Product NDC 40089-113
Product ID 40089-113_4123350b-7aed-3663-e063-6394a90ac1eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204514
Listing Expiration 2026-12-31
Marketing Start 2012-03-21

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 40089113
Hyphenated Format 40089-113

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 ANDA204514 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 37.5 mCi/mL
source: ndc
Packaging
  • 20 mL in 1 VIAL, GLASS (40089-113-20)
source: ndc

Packages (1)

40089-113-20 20 mL in 1 VIAL, GLASS (40089-113-20)

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": "4123350b-7aed-3663-e063-6394a90ac1eb", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["9OQO0E343Z"], "spl_set_id": ["80121d8f-fb9d-4122-9e12-33b4ba4f2b9a"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["The Johns Hopkins University"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 mL in 1 VIAL, GLASS (40089-113-20)", "package_ndc": "40089-113-20", "marketing_start_date": "20120321"}], "brand_name": "Ammonia N 13", "product_id": "40089-113_4123350b-7aed-3663-e063-6394a90ac1eb", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "40089-113", "generic_name": "NH3N13", "labeler_name": "The Johns Hopkins University", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ammonia N 13", "active_ingredients": [{"name": "AMMONIA N-13", "strength": "37.5 mCi/mL"}], "application_number": "ANDA204514", "marketing_category": "ANDA", "marketing_start_date": "20120321", "listing_expiration_date": "20261231"}