balsalazide disodium
- Product NDC
- 70710-1626
- 11-digit product format
- 707101626
- Labeler code
- 70710
- Product ID
- 70710-1626_5364926a-5a07-440a-a27e-1435a9e4d4f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- balsalazide disodium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA217592
- Marketing category
- ANDA
- Marketing start
- 2023-08-25
- Substance
- BALSALAZIDE DISODIUM
- Active strength
- 750 mg/1
- Pharmacologic classes
- Aminosalicylate [EPC], Aminosalicylic Acids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- balsalazide disodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BALSALAZIDE DISODIUM | 750 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1XL6BJI034 |
| Rxcui | 885857 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70710-1626-1 | balsalazide disodium | 280 in 1 BOTTLE | CAPSULE | 280 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-1626 | BALSALAZIDE DISODIUM CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | Current NDC, 1 package rows | 20240330_0ed73067-e2ca-4184-a93a-5a2141bb4898.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70710-1626-1 | 70710162601 | 280 CAPSULE in 1 BOTTLE (70710-1626-1) | 280 capsule | 2023-08-25 | No | No | Historical |