NDC 65857-200

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 Cardinal Health 414, Llc. The primary component is Ammonia N-13.

• Product ID: 65857-200_886dbcba-5cf9-4d8b-95c0-d4fc574e8e02
• NDC: 65857-200
• 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: 2013-02-25
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203700
• Labeler Name: Cardinal Health 414, LLC
• Substance Name: AMMONIA N-13
• Active Ingredient Strength: 38 mCi/mL
• Pharm Classes: Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 65857-200-10

10 mL in 1 VIAL, GLASS (65857-200-10)

• Marketing Start Date: 2013-02-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65857-200-10 [65857020010]

Ammonia N-13 INJECTION

• Marketing Category: ANDA
• Application Number: ANDA203700
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-02-25

Drug Details

Active Ingredients

Ingredient	Strength
AMMONIA N-13	37.5 mCi/mL

OpenFDA Data

• SPL SET ID: 4c563174-c7cd-4224-b865-4da2f39c21c0
• Manufacturer:
  • Cardinal Health 414, LLC
• UNII:
  • 9OQO0E343Z

Pharmacological Class

• Radioactive Diagnostic Agent [EPC]
• Radiopharmaceutical Activity [MoA]
• 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
24450-113	AMMONIA N-13	AMMONIA N-13
52768-100	AMMONIA N-13	AMMONIA N-13
69864-002	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
65857-200	Ammonia	Ammonia N-13
70681-001	Ammonia	AMMONIA N-13
24445-643	Ammonia N 13	AMMONIA N-13
24562-004	Ammonia N 13	Ammonia N-13
40028-513	Ammonia N 13	Ammonia N-13
44338-002	Ammonia N 13	Ammonia N-13
49609-201	Ammonia N 13	Ammonia N-13
52670-552	Ammonia N 13	ammonia n-13
71162-001	Ammonia N 13	Ammonia N-13
76318-643	Ammonia N 13	ammonia n-13
76394-3812	Ammonia N 13	AMMONIA N-13
76167-003	AmmoniaN 13	AMMONIA N-13