PRODUCT NDC | 0378-9692 | 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 | Levalbuterol | 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 | Levalbuterol | 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 | SOLUTION | The translation of the dosage form Code submitted by the firm. |
ROUTE NAME | RESPIRATORY (INHALATION) | 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. |
START MARKETING DATE | 9/10/2018 | The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
MARKETING CATEGORY NAME | ANDA | A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
APPLICATION NUMBER | ANDA203653 | The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
LABELER NAME | Mylan Pharmaceuticals Inc. | The translation of the dosage form Code submitted by the firm. |
SUBSTANCE NAME | LEVALBUTEROL HYDROCHLORIDE | The translation of the route code submitted by the firm, indicating route of administration. |
ACTIVE NUMERATOR STRENGTH | 1.25 | |
ACTIVE INGRED UNIT | mg/3mL | |
PHARM CLASSES | Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC] | |