ammonia n 13

Generic: ammonia n-13

Labeler: massachusetts general hospital
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ammonia n 13
Generic Name ammonia n-13
Labeler massachusetts general hospital
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ammonia n-13 37.5 mCi/mL

Manufacturer
Massachusetts General Hospital

Identifiers & Regulatory

Product NDC 76318-643
Product ID 76318-643_483561c7-747d-40a7-8ed7-134eac3da69c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207025
Listing Expiration 2026-12-31
Marketing Start 2016-02-03

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 76318643
Hyphenated Format 76318-643

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 ANDA207025 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 37.5 mCi/mL
source: ndc
Packaging
  • 30 mL in 1 VIAL (76318-643-30)
source: ndc

Packages (1)

76318-643-30 30 mL in 1 VIAL (76318-643-30)

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": "483561c7-747d-40a7-8ed7-134eac3da69c", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["9OQO0E343Z"], "spl_set_id": ["57947a8c-939e-4468-805c-2f2001041fe4"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["Massachusetts General Hospital"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 VIAL (76318-643-30)", "package_ndc": "76318-643-30", "marketing_start_date": "20160203"}], "brand_name": "Ammonia N 13", "product_id": "76318-643_483561c7-747d-40a7-8ed7-134eac3da69c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "76318-643", "generic_name": "ammonia n-13", "labeler_name": "Massachusetts General Hospital", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ammonia N 13", "active_ingredients": [{"name": "AMMONIA N-13", "strength": "37.5 mCi/mL"}], "application_number": "ANDA207025", "marketing_category": "ANDA", "marketing_start_date": "20160203", "listing_expiration_date": "20261231"}