Diatrizoate Meglumine and Diatrizoate Sodium
- Product NDC
- 53041-688
- 11-digit product format
- 530410688
- Labeler code
- 53041
- Product ID
- 53041-688_9cfdb214-1075-4449-9a01-f04cf5d0edfe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diatrizoate Meglumine and Diatrizoate Sodium
- Dosage form
- SOLUTION
- Route
- ORAL; RECTAL
- Labeler
- Guardian Drug Company
- Application
- ANDA214201
- Marketing category
- ANDA
- Marketing start
- 2019-12-18
- 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| Ingredient | Strength |
|---|
| DIATRIZOATE MEGLUMINE | 660 mg/mL |
| DIATRIZOATE SODIUM | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3X9MR4N98U, V5403H8VG7 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53041-688-03 | Diatrizoate Meglumine and Diatrizoate Sodium | 120 mL in 1 BOTTLE, PLASTIC | SOLUTION | 120 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53041-688 | DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM SOLUTION [GUARDIAN DRUG COMPANY] | 3 | Current NDC, Legacy NDC, 1 package rows | 20220706_e9da4d3d-d0ca-44f7-aaeb-ae49c3839775.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53041-688-03 | 53041068803 | 120 mL in 1 BOTTLE, PLASTIC (53041-688-03) | 120 ml | 2019-12-18 | 0000-00-00 | No | No | Current |