ammonia n-13

Generic: ammonia n-13

Labeler: the methodist hospital research institute
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ammonia n-13
Generic Name ammonia n-13
Labeler the methodist hospital research institute
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

ammonia n-13 260 mCi/mL

Manufacturer
The Methodist Hospital Research Institute

Identifiers & Regulatory

Product NDC 69864-002
Product ID 69864-002_0ce4c7b6-2913-fecf-e063-6394a90ab438
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215083
Listing Expiration 2026-12-31
Marketing Start 2021-07-09

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 69864002
Hyphenated Format 69864-002

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 ANDA215083 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 260 mCi/mL
source: ndc
Packaging
  • 6 mL in 1 VIAL, GLASS (69864-002-30)
source: ndc

Packages (1)

69864-002-30 6 mL in 1 VIAL, GLASS (69864-002-30)

Ingredients (1)

ammonia n-13 (260 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": "0ce4c7b6-2913-fecf-e063-6394a90ab438", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["9OQO0E343Z"], "spl_set_id": ["c79222b1-7dd8-f1fe-e053-2a95a90a3639"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["The Methodist Hospital Research Institute"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 mL in 1 VIAL, GLASS (69864-002-30)", "package_ndc": "69864-002-30", "marketing_start_date": "20210709"}], "brand_name": "Ammonia N-13", "product_id": "69864-002_0ce4c7b6-2913-fecf-e063-6394a90ab438", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "69864-002", "generic_name": "Ammonia N-13", "labeler_name": "The Methodist Hospital Research Institute", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ammonia N-13", "active_ingredients": [{"name": "AMMONIA N-13", "strength": "260 mCi/mL"}], "application_number": "ANDA215083", "marketing_category": "ANDA", "marketing_start_date": "20210709", "listing_expiration_date": "20261231"}