| PRODUCT NDC | 71205-416 | 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 | 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 | MECLIZINE HYDROCHLORIDE | 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 | Meclizine Hydrochloride | 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 | The translation of the dosage form Code submitted by the firm. |
| ROUTE NAME | ORAL | The translation of the route code submitted by the firm, indicating route of administration. |
| START MARKETING DATE | 6/4/2010 | 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 | ANDA040659 | 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. |
| LABELER NAME | Proficient Rx LP | The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
| SUBSTANCE NAME | MECLIZINE HYDROCHLORIDE | The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| ACTIVE NUMERATOR STRENGTH | 12.5 | The translation of the dosage form Code submitted by the firm. |
| ACTIVE INGRED UNIT | mg/1 | The translation of the route code submitted by the firm, indicating route of administration. |
| PHARM CLASSES | Antiemetic [EPC], Emesis Suppression [PE] | |