NDC 16129-003

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 Shertech Laboratories, Llc. The primary component is Ammonia N-13.

Product ID16129-003_5d8041ed-475f-1859-e053-2991aa0abda3
NDC16129-003
Product TypeHuman Prescription Drug
Proprietary NameAmmonia N 13
Generic NameAmmonia N-13
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2012-06-12
Marketing CategoryANDA / ANDA
Application NumberANDA204366
Labeler NameShertech Laboratories, LLC
Substance NameAMMONIA N-13
Active Ingredient Strength260 mCi/mL
Pharm ClassesRadioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 16129-003-30

30 mL in 1 VIAL, GLASS (16129-003-30)
Marketing Start Date2012-06-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16129-003-30 [16129000330]

Ammonia N 13 INJECTION
Marketing CategoryANDA
Application NumberANDA204366
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-06-12

Drug Details

Active Ingredients

IngredientStrength
AMMONIA N-13260 mCi/mL

OpenFDA Data

SPL SET ID:1acbe215-8cbb-491b-a5f5-34bab337aa99
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
71162-001Ammonia N 13Ammonia N 13
75913-113Ammonia N 13Ammonia N 13
76318-643Ammonia N 13Ammonia N 13
76394-3812Ammonia N 13Ammonia N 13
76451-013Ammonia N 13Ammonia N 13
73410-001Ammonia N 13Ammonia N 13
70681-001Ammonia N 13Ammonia N 13
72333-001Ammonia N 13Ammonia N 13
16129-003AmmoniaAMMONIA N-13
47584-003AmmoniaAMMONIA N-13
49609-003AmmoniaAMMONIA N-13
62072-456AmmoniaAMMONIA N-13
24450-113AMMONIA N-13AMMONIA N-13
52768-100AMMONIA N-13AMMONIA N-13

Trademark Results [Ammonia]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AMMONIA
AMMONIA
75057807 2116798 Dead/Cancelled
Ammonia
1996-02-14

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