Colesevelam is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Colesevelam Hydrochloride.
| Product ID | 68382-619_4ed4ab9b-5dd2-4132-88d0-55b28d58ba2e |
| NDC | 68382-619 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Colesevelam |
| Generic Name | Colesevelam |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-10-11 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA207765 |
| Labeler Name | Zydus Pharmaceuticals (USA) Inc. |
| 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 | 2021-12-31 |
| 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 |
| Billing Unit | EA |
| 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: | 6a26e745-7e38-4af0-9bcc-566b2812df75 |
| 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 |