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Diatrizoate Meglumine and Diatrizoate Sodium

Diatrizoate Meglumine and Diatrizoate Sodium Solution, USP

Approved
Approval ID

a216a7d5-3c28-482b-956a-93ae146e3763

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 18, 2023

Manufacturers
FDA

Camber Pharmaceuticals, Inc.

DUNS: 826774775

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Diatrizoate Meglumine and Diatrizoate Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code31722-019
Application NumberANDA215049
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diatrizoate Meglumine and Diatrizoate Sodium
Product Specifications
Route of AdministrationORAL, RECTAL
Effective DateDecember 18, 2023
FDA Product Classification

INGREDIENTS (9)

EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
DIATRIZOATE SODIUMActive
Quantity: 100 mg in 1 mL
Code: V5403H8VG7
Classification: ACTIB
DIATRIZOATE MEGLUMINEActive
Quantity: 660 mg in 1 mL
Code: 3X9MR4N98U
Classification: ACTIB

Drug Labeling Information

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 12/11/2023

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.

Camber_logo

Manufactured for:
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854

By: Annora Pharma Pvt. Ltd.
Sangareddy - 502313, Telangana, India.

Revised: 11/2023

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Diatrizoate Meglumine and Diatrizoate Sodium - FDA Drug Approval Details