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 ID: 16129-003_5d8041ed-475f-1859-e053-2991aa0abda3
• NDC: 16129-003
• Product Type: Human Prescription Drug
• Proprietary Name: Ammonia N 13
• Generic Name: Ammonia N-13
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2012-06-12
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204366
• Labeler Name: Shertech Laboratories, LLC
• Substance Name: AMMONIA N-13
• Active Ingredient Strength: 260 mCi/mL
• Pharm Classes: Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 16129-003-30

30 mL in 1 VIAL, GLASS (16129-003-30)

• Marketing Start Date: 2012-06-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16129-003-30 [16129000330]

Ammonia N 13 INJECTION

• Marketing Category: ANDA
• Application Number: ANDA204366
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-06-12

Drug Details

Active Ingredients

Ingredient	Strength
AMMONIA N-13	260 mCi/mL

OpenFDA Data

• SPL SET ID: 1acbe215-8cbb-491b-a5f5-34bab337aa99
• Manufacturer:
  • Shertech Laboratories, LLC
• UNII:
  • 9OQO0E343Z

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
13108-311	Ammonia N 13	Ammonia N 13
13267-456	Ammonia N 13	NH3N13
24275-0385	Ammonia N 13	NH3N13
24445-643	Ammonia N 13	AMMONIA N-13
24562-004	Ammonia N 13	Ammonia N-13
40028-513	Ammonia N 13	Ammonia N-13
40089-113	Ammonia N 13	NH3N13
44338-002	Ammonia N 13	Ammonia N-13
49609-201	Ammonia N 13	Ammonia N-13
51760-003	Ammonia N 13	NH3N13
52670-552	Ammonia N 13	ammonia n-13
69126-001	Ammonia N 13	Ammonia N 13
71162-001	Ammonia N 13	Ammonia N 13
75913-113	Ammonia N 13	Ammonia N 13
76318-643	Ammonia N 13	Ammonia N 13
76394-3812	Ammonia N 13	Ammonia N 13
76451-013	Ammonia N 13	Ammonia N 13
73410-001	Ammonia N 13	Ammonia N 13
70681-001	Ammonia N 13	Ammonia N 13
72333-001	Ammonia N 13	Ammonia N 13
16129-003	Ammonia	AMMONIA N-13
47584-003	Ammonia	AMMONIA N-13
49609-003	Ammonia	AMMONIA N-13
62072-456	Ammonia	AMMONIA N-13
24450-113	AMMONIA N-13	AMMONIA N-13
52768-100	AMMONIA N-13	AMMONIA N-13