Miglitol is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Orient Pharma Co., Ltd.. The primary component is Miglitol.
| Product ID | 76333-125_71fe01c0-610b-477e-8709-d194ebde8624 |
| NDC | 76333-125 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Miglitol |
| Generic Name | Miglitol |
| Dosage Form | Tablet, Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2015-07-31 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA203965 |
| Labeler Name | Orient Pharma Co., Ltd. |
| Substance Name | MIGLITOL |
| Active Ingredient Strength | 25 mg/1 |
| Pharm Classes | alpha Glucosidase Inhibitors [MoA],alpha-Glucosidase Inhibitor [EPC] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
| Marketing Start Date | 2019-10-23 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA203965 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-10-23 |
| Marketing Category | ANDA |
| Application Number | ANDA203965 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-10-23 |
| Ingredient | Strength |
|---|---|
| MIGLITOL | 25 mg/1 |
| SPL SET ID: | 192e6ed7-9e8c-4772-9e3b-5912a1c63a31 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 57664-684 | Miglitol | Miglitol |
| 57664-685 | Miglitol | Miglitol |
| 57664-686 | Miglitol | Miglitol |
| 69367-303 | Miglitol | Miglitol |
| 69367-304 | Miglitol | Miglitol |
| 69367-305 | Miglitol | Miglitol |
| 71205-935 | Miglitol | Miglitol |
| 71205-936 | Miglitol | Miglitol |
| 71205-937 | Miglitol | Miglitol |
| 76333-125 | Miglitol | Miglitol |
| 76333-126 | Miglitol | Miglitol |
| 76333-127 | Miglitol | Miglitol |
| 0009-5012 | Glyset | miglitol |
| 0009-5013 | Glyset | miglitol |
| 0009-5014 | Glyset | miglitol |