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-13 260 mCi/mL

Manufacturer
SOFIE Co. dba SOFIE

Identifiers & Regulatory

Product NDC 49609-003
Product ID 49609-003_31e5cc40-daff-bea7-e063-6294a90a5aa4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203543
Listing Expiration 2026-12-31
Marketing Start 2011-08-04

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 49609003
Hyphenated Format 49609-003

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 ANDA203543 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 260 mCi/mL
source: ndc
Packaging
  • 30 mL in 1 VIAL, GLASS (49609-003-01)
source: ndc

Packages (1)

49609-003-01 30 mL in 1 VIAL, GLASS (49609-003-01)

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": "31e5cc40-daff-bea7-e063-6294a90a5aa4", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["9OQO0E343Z"], "spl_set_id": ["85882893-0661-46c2-a5f2-a73f6ea4fb5a"], "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, GLASS (49609-003-01)", "package_ndc": "49609-003-01", "marketing_start_date": "20110804"}], "brand_name": "Ammonia N 13", "product_id": "49609-003_31e5cc40-daff-bea7-e063-6294a90a5aa4", "dosage_form": "INJECTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "49609-003", "generic_name": "AMMONIA N-13", "labeler_name": "SOFIE Co. dba SOFIE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ammonia", "brand_name_suffix": "N 13", "active_ingredients": [{"name": "AMMONIA N-13", "strength": "260 mCi/mL"}], "application_number": "ANDA203543", "marketing_category": "ANDA", "marketing_start_date": "20110804", "listing_expiration_date": "20261231"}