ammonia n 13

Generic: ammonia n 13

Labeler: sofie co. dba sofie
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ammonia n 13
Generic Name ammonia n 13
Labeler sofie co. dba sofie
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

ammonia n-13 37.5 mCi/mL

Manufacturer
SOFIE Co. dba SOFIE

Identifiers & Regulatory

Product NDC 73410-001
Product ID 73410-001_31be36fd-e20b-e449-e063-6294a90aec4c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204465
Listing Expiration 2026-12-31
Marketing Start 2019-11-06

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 73410001
Hyphenated Format 73410-001

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 ANDA204465 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 37.5 mCi/mL
source: ndc
Packaging
  • 30 mL in 1 VIAL, MULTI-DOSE (73410-001-01)
source: ndc

Packages (1)

73410-001-01 30 mL in 1 VIAL, MULTI-DOSE (73410-001-01)

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": "31be36fd-e20b-e449-e063-6294a90aec4c", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["9OQO0E343Z"], "spl_set_id": ["d24f8595-2231-4f15-ac2b-9148ec453324"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["SOFIE Co. dba SOFIE"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 VIAL, MULTI-DOSE (73410-001-01)", "package_ndc": "73410-001-01", "marketing_start_date": "20191106"}], "brand_name": "Ammonia N 13", "product_id": "73410-001_31be36fd-e20b-e449-e063-6294a90aec4c", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "73410-001", "generic_name": "Ammonia N 13", "labeler_name": "SOFIE Co. dba SOFIE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ammonia N 13", "active_ingredients": [{"name": "AMMONIA N-13", "strength": "37.5 mCi/mL"}], "application_number": "ANDA204465", "marketing_category": "ANDA", "marketing_start_date": "20191106", "listing_expiration_date": "20261231"}