ammonia n 13

Generic: ammonia n-13

Labeler: 3d imaging drug design and development llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ammonia n 13
Generic Name ammonia n-13
Labeler 3d imaging drug design and development llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

ammonia n-13 37.5 mCi/mL

Manufacturer
3D Imaging Drug Design and Development LLC

Identifiers & Regulatory

Product NDC 76451-013
Product ID 76451-013_47d37f1c-3d95-ec07-e063-6394a90a8d2f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203779
Listing Expiration 2027-12-31
Marketing Start 2012-01-02

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 76451013
Hyphenated Format 76451-013

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 ANDA203779 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 37.5 mCi/mL
source: ndc
Packaging
  • 10 mL in 1 VIAL, GLASS (76451-013-10)
source: ndc

Packages (1)

76451-013-10 10 mL in 1 VIAL, GLASS (76451-013-10)

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": "47d37f1c-3d95-ec07-e063-6394a90a8d2f", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["9OQO0E343Z"], "spl_set_id": ["fce62c22-a1e2-4193-8de5-e1961d9b94a5"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["3D Imaging Drug Design and Development LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 VIAL, GLASS (76451-013-10)", "package_ndc": "76451-013-10", "marketing_start_date": "20181217"}], "brand_name": "Ammonia N 13", "product_id": "76451-013_47d37f1c-3d95-ec07-e063-6394a90a8d2f", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "76451-013", "generic_name": "AMMONIA N-13", "labeler_name": "3D Imaging Drug Design and Development 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": "ANDA203779", "marketing_category": "ANDA", "marketing_start_date": "20120102", "listing_expiration_date": "20271231"}