NDC 69126-001

Ammonia N 13

Ammonia N 13

Ammonia N 13 is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Global Isotopes, Llc D/b/a Zevacor Molecular. The primary component is Ammonia N-13.

Product ID69126-001_5d8e94f9-8c33-e3cb-e053-2a91aa0a84e1
NDC69126-001
Product TypeHuman Prescription Drug
Proprietary NameAmmonia N 13
Generic NameAmmonia N 13
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA204465
Labeler NameGlobal Isotopes, LLC d/b/a Zevacor Molecular
Substance NameAMMONIA N-13
Active Ingredient Strength38 mCi/mL
Pharm ClassesRadioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 69126-001-01

30 mL in 1 VIAL, MULTI-DOSE (69126-001-01)
Marketing Start Date2014-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69126-001-01 [69126000101]

Ammonia N 13 INJECTION
Marketing CategoryANDA
Application NumberANDA204465
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-31
Marketing End Date2019-05-17

Drug Details

Active Ingredients

IngredientStrength
AMMONIA N-1337.5 mCi/mL

OpenFDA Data

SPL SET ID:967407b9-621e-4165-a245-11bf577497d6
Manufacturer
UNII

Pharmacological Class

  • Radioactive Diagnostic Agent [EPC]
  • Radiopharmaceutical Activity [MoA]

NDC Crossover Matching brand name "Ammonia N 13" or generic name "Ammonia N 13"

NDCBrand NameGeneric Name
13108-311Ammonia N 13Ammonia N 13
13267-456Ammonia N 13NH3N13
24275-0385Ammonia N 13NH3N13
24445-643Ammonia N 13AMMONIA N-13
24562-004Ammonia N 13Ammonia N-13
40028-513Ammonia N 13Ammonia N-13
40089-113Ammonia N 13NH3N13
44338-002Ammonia N 13Ammonia N-13
49609-201Ammonia N 13Ammonia N-13
51760-003Ammonia N 13NH3N13
52670-552Ammonia N 13ammonia n-13
69126-001Ammonia N 13Ammonia N 13
69714-001Ammonia N 13NH3N13
71162-001Ammonia N 13Ammonia N-13
72333-001Ammonia N 13Ammonia N 13
73410-001Ammonia N 13Ammonia N 13
75913-113Ammonia N 13NH3N13
76318-643Ammonia N 13Ammonia N 13
76394-3812Ammonia N 13Ammonia N 13
76451-013Ammonia N 13Ammonia N 13
16129-003Ammonia N 13Ammonia N 13
47584-003Ammonia N 13Ammonia N 13
62072-456Ammonia N 13Ammonia N 13
70681-001Ammonia N 13Ammonia N 13
49609-003Ammonia N 13Ammonia N 13

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