COLESEVELAM is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is Colesevelam Hydrochloride.
| Product ID | 70771-1368_47ee247c-041c-4eaa-bc2e-831064e6d4db |
| NDC | 70771-1368 |
| Product Type | Human Prescription Drug |
| Proprietary Name | COLESEVELAM |
| Generic Name | Colesevelam |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-10-11 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA207765 |
| Labeler Name | Zydus Lifesciences Limited |
| Substance Name | COLESEVELAM HYDROCHLORIDE |
| Active Ingredient Strength | 625 mg/1 |
| Pharm Classes | Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2019-10-11 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA207765 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-10-11 |
| Marketing Category | ANDA |
| Application Number | ANDA207765 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-10-11 |
| Marketing Category | ANDA |
| Application Number | ANDA207765 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-10-11 |
| Marketing Category | ANDA |
| Application Number | ANDA207765 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-10-11 |
| Ingredient | Strength |
|---|---|
| COLESEVELAM HYDROCHLORIDE | 625 mg/1 |
| SPL SET ID: | 090eabd5-acd3-43ed-a05b-52f1f3773a93 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 27808-190 | Colesevelam | Colesevelam |
| 68382-619 | Colesevelam | Colesevelam |
| 70771-1368 | COLESEVELAM | COLESEVELAM |