diatrizoate meglumine and diatrizoate sodium

Generic: diatrizoate meglumine and diatrizoate sodium

Labeler: guardian drug company
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diatrizoate meglumine and diatrizoate sodium
Generic Name diatrizoate meglumine and diatrizoate sodium
Labeler guardian drug company
Dosage Form SOLUTION
Routes
ORAL RECTAL
Active Ingredients

diatrizoate meglumine 660 mg/mL, diatrizoate sodium 100 mg/mL

Manufacturer
Guardian Drug Company

Identifiers & Regulatory

Product NDC 53041-688
Product ID 53041-688_9cfdb214-1075-4449-9a01-f04cf5d0edfe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214201
Listing Expiration 2026-12-31
Marketing Start 2019-12-18

Pharmacologic Class

Classes
radiographic contrast agent [epc] x-ray contrast activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53041688
Hyphenated Format 53041-688

Supplemental Identifiers

UNII
3X9MR4N98U V5403H8VG7

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name diatrizoate meglumine and diatrizoate sodium (source: ndc)
Generic Name diatrizoate meglumine and diatrizoate sodium (source: ndc)
Application Number ANDA214201 (source: ndc)
Routes
ORAL RECTAL
source: ndc

Resolved Composition

Strengths
  • 660 mg/mL
  • 100 mg/mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE, PLASTIC (53041-688-03)
source: ndc

Packages (1)

53041-688-03 120 mL in 1 BOTTLE, PLASTIC (53041-688-03)

Ingredients (2)

diatrizoate meglumine (660 mg/mL) diatrizoate sodium (100 mg/mL)

Linked Drug Pages (1)

Diatrizoate Meglumine and Diatrizoate Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL", "RECTAL"], "spl_id": "9cfdb214-1075-4449-9a01-f04cf5d0edfe", "openfda": {"unii": ["3X9MR4N98U", "V5403H8VG7"], "spl_set_id": ["e9da4d3d-d0ca-44f7-aaeb-ae49c3839775"], "manufacturer_name": ["Guardian Drug Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (53041-688-03)", "package_ndc": "53041-688-03", "marketing_start_date": "20191218"}], "brand_name": "Diatrizoate Meglumine and Diatrizoate Sodium", "product_id": "53041-688_9cfdb214-1075-4449-9a01-f04cf5d0edfe", "dosage_form": "SOLUTION", "pharm_class": ["Radiographic Contrast Agent [EPC]", "Radiographic Contrast Agent [EPC]", "X-Ray Contrast Activity [MoA]", "X-Ray Contrast Activity [MoA]"], "product_ndc": "53041-688", "generic_name": "Diatrizoate Meglumine and Diatrizoate Sodium", "labeler_name": "Guardian Drug Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diatrizoate Meglumine and Diatrizoate Sodium", "active_ingredients": [{"name": "DIATRIZOATE MEGLUMINE", "strength": "660 mg/mL"}, {"name": "DIATRIZOATE SODIUM", "strength": "100 mg/mL"}], "application_number": "ANDA214201", "marketing_category": "ANDA", "marketing_start_date": "20191218", "listing_expiration_date": "20261231"}