| PRODUCT NDC | 62135-803 | 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. |
| PRODUCT TYPE NAME | HUMAN PRESCRIPTION DRUG | 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. |
| PROPRIETARY NAME | Acyclovir | Name of Company corresponding to the labeler code segment of the Product NDC. |
| NON PROPRIETARY NAME | Acyclovir | 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 | SUSPENSION | |
| ROUTE NAME | ORAL | The translation of the route code submitted by the firm, indicating route of administration. |
| START MARKETING DATE | 4/23/2020 | |
| 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 | ANDA212718 | 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 | Chartwell RX, LLC | Name of Company corresponding to the labeler code segment of the Product NDC. |
| SUBSTANCE NAME | ACYCLOVIR | 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 | 200 | |
| ACTIVE INGRED UNIT | mg/5mL | |
| PHARM CLASSES | DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT] | |