balsalazide disodium
- Product NDC
- 80005-126
- 11-digit product format
- 800050126
- Labeler code
- 80005
- Product ID
- 80005-126_8bfef633-a30b-4aac-b768-cce1c8e151c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- balsalazide disodium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Carnegie Pharmaceuticals, LLC
- Application
- ANDA219422
- Marketing category
- ANDA
- Marketing start
- 2025-06-30
- 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 |
|---|
| 80005-126-25 | balsalazide disodium | 280 in 1 BOTTLE | CAPSULE | 280 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80005-126-25 | 80005012625 | 280 CAPSULE in 1 BOTTLE (80005-126-25) | 280 capsule | 2025-06-30 | No | No | Current |