ammonia n-13

Generic: ammonia n-13

Labeler: precision nuclear llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ammonia n-13
Generic Name ammonia n-13
Labeler precision nuclear llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ammonia n-13 260 mCi/mL

Manufacturer
Precision Nuclear LLC

Identifiers & Regulatory

Product NDC 52768-100
Product ID 52768-100_318c2020-f260-4b67-8df3-95ee2cf2b49e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204547
Listing Expiration 2026-12-31
Marketing Start 2010-10-10

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 52768100
Hyphenated Format 52768-100

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 ANDA204547 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 260 mCi/mL
source: ndc
Packaging
  • 3 mL in 1 SYRINGE (52768-100-03)
  • 5 mL in 1 SYRINGE (52768-100-05)
  • 30 mL in 1 VIAL, MULTI-DOSE (52768-100-30)
  • 50 mL in 1 VIAL, MULTI-DOSE (52768-100-50)
source: ndc

Packages (4)

52768-100-03 3 mL in 1 SYRINGE (52768-100-03) 52768-100-05 5 mL in 1 SYRINGE (52768-100-05) 52768-100-30 30 mL in 1 VIAL, MULTI-DOSE (52768-100-30) 52768-100-50 50 mL in 1 VIAL, MULTI-DOSE (52768-100-50)

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": "318c2020-f260-4b67-8df3-95ee2cf2b49e", "openfda": {"nui": ["N0000177914", "N0000000205"], "unii": ["9OQO0E343Z"], "spl_set_id": ["cc430bfd-6940-41ca-bda4-6d29eb4dc1f2"], "pharm_class_epc": ["Radioactive Diagnostic Agent [EPC]"], "pharm_class_moa": ["Radiopharmaceutical Activity [MoA]"], "manufacturer_name": ["Precision Nuclear LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 mL in 1 SYRINGE (52768-100-03)", "package_ndc": "52768-100-03", "marketing_start_date": "20171001"}, {"sample": false, "description": "5 mL in 1 SYRINGE (52768-100-05)", "package_ndc": "52768-100-05", "marketing_start_date": "20171001"}, {"sample": false, "description": "30 mL in 1 VIAL, MULTI-DOSE (52768-100-30)", "package_ndc": "52768-100-30", "marketing_start_date": "20101010"}, {"sample": false, "description": "50 mL in 1 VIAL, MULTI-DOSE (52768-100-50)", "package_ndc": "52768-100-50", "marketing_start_date": "20101010"}], "brand_name": "AMMONIA N-13", "product_id": "52768-100_318c2020-f260-4b67-8df3-95ee2cf2b49e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radioactive Diagnostic Agent [EPC]", "Radiopharmaceutical Activity [MoA]"], "product_ndc": "52768-100", "generic_name": "AMMONIA N-13", "labeler_name": "Precision Nuclear LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMMONIA N-13", "active_ingredients": [{"name": "AMMONIA N-13", "strength": "260 mCi/mL"}], "application_number": "ANDA204547", "marketing_category": "ANDA", "marketing_start_date": "20101010", "listing_expiration_date": "20261231"}