ammonia n-13

Generic: ammonia n-13

Labeler: cardinal health 414, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ammonia n-13
Generic Name ammonia n-13
Labeler cardinal health 414, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

ammonia n-13 37.5 mCi/mL

Manufacturer
Cardinal Health 414, LLC

Identifiers & Regulatory

Product NDC 65857-200
Product ID 65857-200_886dbcba-5cf9-4d8b-95c0-d4fc574e8e02
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203700
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 65857200
Hyphenated Format 65857-200

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 ANDA203700 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 37.5 mCi/mL
source: ndc
Packaging
  • 10 mL in 1 VIAL, GLASS (65857-200-10)
source: ndc

Packages (1)

65857-200-10 10 mL in 1 VIAL, GLASS (65857-200-10)

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": "886dbcba-5cf9-4d8b-95c0-d4fc574e8e02", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["9OQO0E343Z"], "spl_set_id": ["4c563174-c7cd-4224-b865-4da2f39c21c0"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["Cardinal Health 414, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 VIAL, GLASS (65857-200-10)", "package_ndc": "65857-200-10", "marketing_start_date": "20130225"}], "brand_name": "Ammonia N-13", "product_id": "65857-200_886dbcba-5cf9-4d8b-95c0-d4fc574e8e02", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "65857-200", "generic_name": "Ammonia N-13", "labeler_name": "Cardinal Health 414, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ammonia", "brand_name_suffix": "N-13", "active_ingredients": [{"name": "AMMONIA N-13", "strength": "37.5 mCi/mL"}], "application_number": "ANDA203700", "marketing_category": "ANDA", "marketing_start_date": "20130225", "listing_expiration_date": "20261231"}