NDC 69126-004

Choline C 11

Choline C11

Choline C 11 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 Choline C-11.

• Product ID: 69126-004_5d7fc9e5-163d-edc8-e053-2a91aa0a934e
• NDC: 69126-004
• Product Type: Human Prescription Drug
• Proprietary Name: Choline C 11
• Generic Name: Choline C11
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2015-12-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206319
• Labeler Name: Global Isotopes, LLC d/b/a Zevacor Molecular
• Substance Name: CHOLINE C-11
• Active Ingredient Strength: 4 mCi/mL
• Pharm Classes: Radioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 69126-004-01

30 mL in 1 VIAL, MULTI-DOSE (69126-004-01)

• Marketing Start Date: 2017-11-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69126-004-01 [69126000401]

Choline C 11 INJECTION

• Marketing Category: ANDA
• Application Number: ANDA206319
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-11-14
• Marketing End Date: 2019-05-17

Drug Details

Active Ingredients

Ingredient	Strength
CHOLINE C-11	4 mCi/mL

OpenFDA Data

• SPL SET ID: 04ae6f89-aa78-42c2-ab28-7685852346ab
• Manufacturer:
  • Global Isotopes, LLC d/b/a Zevacor Molecular
• UNII:
  • M4AS4XGD4Q

Pharmacological Class

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

NDC Crossover Matching brand name "Choline C 11" or generic name "Choline C11"

NDC	Brand Name	Generic Name
24275-0485	Choline C 11	Choline C-11
52670-556	Choline C 11	Choline C-11
60215-111	Choline C 11	Choline C 11
69126-004	Choline C 11	Choline C11
73410-004	Choline C 11	Choline C 11
75913-311	Choline C 11	Choline C-11