Balsalazide Disodium
- Product NDC
- 72789-149
- 11-digit product format
- 727890149
- Labeler code
- 72789
- Product ID
- 72789-149_40a76214-2087-acc4-e063-6394a90ae00e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Balsalazide Disodium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA077806
- Marketing category
- ANDA
- Marketing start
- 2007-12-28
- 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 |
|---|
| 72789-149-69 | Balsalazide Disodium | 280 in 1 BOTTLE, PLASTIC | CAPSULE | 280 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-149 | BALSALAZIDE DISODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 15 | Current NDC, Legacy NDC, 1 package rows | 20240719_b3ecc533-dd55-4a2f-84c4-ecd454aae766.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72789-149-69 | 72789014969 | 280 CAPSULE in 1 BOTTLE, PLASTIC (72789-149-69) | 280 capsule | 2020-12-02 | 0000-00-00 | No | No | Current |