| PRODUCT NDC | 68788-8371 | 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. |
| PRODUCT TYPE NAME | HUMAN PRESCRIPTION DRUG | Name of Company corresponding to the labeler code segment of the Product NDC. |
| PROPRIETARY NAME | escitalopram oxalate | 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. |
| NON PROPRIETARY NAME | escitalopram oxalate | |
| DOSAGE FORM NAME | TABLET | |
| ROUTE NAME | ORAL | |
| START MARKETING DATE | 2/1/2023 | This is the date that the labeler indicates was the start of its marketing of the drug product. |
| MARKETING CATEGORY NAME | ANDA | Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| APPLICATION NUMBER | ANDA090939 | 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 | Preferred Pharmaceuticals Inc. | Name of Company corresponding to the labeler code segment of the Product NDC. |
| SUBSTANCE NAME | ESCITALOPRAM OXALATE | 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 | 10 | |
| ACTIVE INGRED UNIT | mg/1 | |
| PHARM CLASSES | Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA] | |