Manufacturing Establishments (1)
Annora Pharma Private Limited
Camber Pharmaceuticals, Inc.
650980746
Products (1)
Diatrizoate Meglumine and Diatrizoate Sodium
31722-019
ANDA215049
ANDA (C73584)
ORAL, RECTAL
December 18, 2023
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81VClass: IACT
DiatrizoateActive
Code: V5403H8VG7Class: ACTIBQuantity: 100 mg in 1 mL
Code: 3X9MR4N98UClass: ACTIBQuantity: 660 mg in 1 mL
Drug Labeling Information
HOW SUPPLIED SECTION
HOW SUPPLIED
Diatrizoate Meglumine and Diatrizoate Sodium Solution USP is available as
clear, aqueous, pale yellow color solution, with strawberry flavor in packages
of:
Twenty-four 30 mL single dose bottles (NDC 31722-019-30).
Twelve 120 mL single dose bottles (NDC 31722-019-12).
Storage
Protect from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; avoid excessive heat.
Manufactured for:
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854
By: Annora Pharma Pvt. Ltd.
Sangareddy - 502313, Telangana, India.
Revised: 11/2023