Colesevelam HCL is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Ascend Laboratories, Llc. The primary component is Colesevelam Hydrochloride.
| Product ID | 67877-506_293d8b43-c7d9-4065-9ee5-743e55915148 |
| NDC | 67877-506 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Colesevelam HCL |
| Generic Name | Colesevelam Hcl |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-10-06 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA209038 |
| Labeler Name | Ascend Laboratories, LLC |
| 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 | 2019-12-31 |
| Marketing Start Date | 2018-10-06 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA209038 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-10-06 |
| Marketing Category | ANDA |
| Application Number | ANDA209038 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-10-06 |
| Marketing Category | ANDA |
| Application Number | ANDA209038 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-10-06 |
| Marketing Category | ANDA |
| Application Number | ANDA209038 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-10-06 |
| Ingredient | Strength |
|---|---|
| COLESEVELAM HYDROCHLORIDE | 625 mg/1 |
| SPL SET ID: | 4ffd02a3-86b8-4af7-b539-aa32e38c6b12 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 50090-4371 | Colesevelam HCL | Colesevelam HCL |
| 63629-8767 | Colesevelam HCL | Colesevelam HCL |
| 67877-506 | Colesevelam HCL | Colesevelam HCL |