Diatrizoate Meglumine and Diatrizoate Sodium

Product NDC
31722-019
11-digit product format
317220019
Labeler code
31722
Product ID
31722-019_2e7917f2-e573-cccb-e063-6294a90a203c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diatrizoate Meglumine and Diatrizoate Sodium
Dosage form
SOLUTION
Route
ORAL; RECTAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA215049
Marketing category
ANDA
Marketing start
2023-11-17
Substance
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
Active strength
660; 100 mg/mL; mg/mL
Pharmacologic classes
Radiographic Contrast Agent [EPC], Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA], X-Ray Contrast Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diatrizoate Meglumine and Diatrizoate Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIATRIZOATE MEGLUMINE660 mg/mL
DIATRIZOATE SODIUM100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X9MR4N98U, V5403H8VG7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a8f1679b-19b1-407c-9ee3-d33055bee6fcProduct name220250731

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-019-12Diatrizoate Meglumine and Diatrizoate Sodium120 mL in 1 BOTTLESOLUTION1203
31722-019-30Diatrizoate Meglumine and Diatrizoate Sodium30 mL in 1 BOTTLESOLUTION303
31722-019-31Diatrizoate Meglumine and Diatrizoate Sodium24 in 1 BOXSOLUTION243
31722-019-32Diatrizoate Meglumine and Diatrizoate Sodium12 in 1 BOXSOLUTION123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-019-12ML - Milliliter31722-019afd9c5b7-0a4e-4594-a046-33694a3c14f012024-09-09
31722-019-30ML - Milliliter31722-019de9410a8-7e7d-42e0-a34a-abab96a8c37612024-09-09
31722-019-31ML - Milliliter31722-019823a1e89-d406-4020-8712-f12e854863bb12024-09-09
31722-019-32ML - Milliliter31722-01951b3dc10-45f5-49e5-8626-c90db4a6645812024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-019DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM) SOLUTION [CAMBER PHARMACEUTICALS, INC.]3Current NDC, 4 package rows20250221_a216a7d5-3c28-482b-956a-93ae146e3763.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-019-1231722001912120 mL in 1 BOTTLE120 mlHistorical
31722-019-303172200193030 mL in 1 BOTTLE30 mlHistorical
31722-019-313172200193124 BOTTLE in 1 BOX (31722-019-31) / 30 mL in 1 BOTTLE (31722-019-30) 24 bottle2023-11-17NoNoCurrent
31722-019-323172200193212 BOTTLE in 1 BOX (31722-019-32) / 120 mL in 1 BOTTLE (31722-019-12) 12 bottle2023-11-17NoNoCurrent