| PRODUCT NDC | 55154-2128 | The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| PRODUCT TYPE NAME | HUMAN PRESCRIPTION DRUG | The translation of the route code submitted by the firm, indicating route of administration. |
| PROPRIETARY NAME | Lisinopril | The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
| NON PROPRIETARY NAME | Lisinopril | 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 | 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. |
| ROUTE NAME | ORAL | Name of Company corresponding to the labeler code segment of the Product NDC. |
| START MARKETING DATE | 1/23/2018 | This is the date that the labeler indicates was the start of its marketing of the drug product. |
| MARKETING CATEGORY NAME | ANDA | |
| APPLICATION NUMBER | ANDA077321 | 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 | Cardinal Health 107, LLC | Name of Company corresponding to the labeler code segment of the Product NDC. |
| SUBSTANCE NAME | LISINOPRIL | 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 | 20 | |
| ACTIVE INGRED UNIT | mg/1 | |
| PHARM CLASSES | Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA] | |