| PRODUCT NDC | 70518-2412 | The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
| PRODUCT TYPE NAME | HUMAN PRESCRIPTION DRUG | Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing. |
| PROPRIETARY NAME | Glimepiride | The translation of the route code submitted by the firm, indicating route of administration. |
| NON PROPRIETARY NAME | Glimepiride | The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| DOSAGE FORM NAME | TABLET | Name of Company corresponding to the labeler code segment of the Product NDC. |
| ROUTE NAME | ORAL | An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted. |
| START MARKETING DATE | 11/10/2019 | |
| MARKETING CATEGORY NAME | ANDA | |
| APPLICATION NUMBER | ANDA078181 | This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| LABELER NAME | REMEDYREPACK INC. | Name of Company corresponding to the labeler code segment of the Product NDC. |
| SUBSTANCE NAME | GLIMEPIRIDE | An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted. |
| ACTIVE NUMERATOR STRENGTH | 1 | |
| ACTIVE INGRED UNIT | mg/1 | |
| PHARM CLASSES | Sulfonylurea Compounds [CS], Sulfonylurea [EPC] | |