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NDC 65649-0101-02 Colazal 750 mg/1 Details
Colazal 750 mg/1
Colazal is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Salix Pharmaceuticals, Inc. The primary component is BALSALAZIDE DISODIUM.
MedlinePlus Drug Summary
Balsalazide is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults and children 5 years of age and older. Balsalazide is an anti-inflammatory drug. It is converted in the body to mesalamine and works by reducing bowel inflammation, diarrhea, rectal bleeding, and stomach pain. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 65649-0101-02Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Balsalazide
Product Information
| NDC | 65649-0101 |
|---|---|
| Product ID | 65649-101_092f61af-2996-0c58-e063-6394a90a3753 |
| Associated GPIs | 52500020100120 |
| GCN Sequence Number | 040304 |
| GCN Sequence Number Description | balsalazide disodium CAPSULE 750 MG ORAL |
| HIC3 | D6F |
| HIC3 Description | DRUG TX-CHRONIC INFLAM. COLON DX,5-AMINOSALICYLAT |
| GCN | 95348 |
| HICL Sequence Number | 018569 |
| HICL Sequence Number Description | BALSALAZIDE DISODIUM |
| Brand/Generic | Brand |
| Proprietary Name | Colazal |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | balsalazide disodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 750 |
| Active Ingredient Units | mg/1 |
| Substance Name | BALSALAZIDE DISODIUM |
| Labeler Name | Salix Pharmaceuticals, Inc |
| Pharmaceutical Class | Aminosalicylate [EPC], Aminosalicylic Acids [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA020610 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65649-0101-02 (65649010102)
| NDC Package Code | 65649-101-02 |
|---|---|
| Billing NDC | 65649010102 |
| Package | 280 CAPSULE in 1 BOTTLE (65649-101-02) |
| Marketing Start Date | 2000-07-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |