Q1-Q4 2019 Prescription Drugs Introduced to Market

Prescription Drugs Introduced to Market

The entity that 1) holds the NDC for a prescription drug; and 2) Is described in Health and Safety Code Section 127675.

Manufacturer Name

A three-segment code maintained by the federal Food and Drug Administration that includes a labeler code, a product code, and a package code for a drug product and that has been converted to an 11-digit format consisting of five digits in the first segment, four digits in the second segment, and two digits in the third segment. A three-segment code shall be considered converted to an 11-digit format when, as necessary, at least one “0” has been added to the front of each segment containing less than the specified amount of digits such that each segment contains the specified amount of digits. 

NDC Number

The finished dosage form of a prescription drug that contains a drug substance, generally, but not necessarily, in association with other active or inactive ingredients, and that has a unique NDC. 

Drug Product Description

The date the new prescription drug was, or will be, introduced to market.

Introduced to Market Date

“Wholesale Acquisition Cost” (WAC) of the new presciption drug as of the introduction to market date.  It is the manufacturer’s published list price for a prescription drug product with a unique NDC.  Reported in US currency, dollars.

WAC at Introduction  

A narrative description of the marketing and pricing plans used in the launch of the new prescription drug in the United States and internationally.

Marketing/Pricing Plan Description

A manufacturer may limit the information reported to that which is otherwise in the public domain or publicly available. An indicator of 1 means that the information is not in the public domain or publicaly available.

Marketing/Pricing Plan Non-Public Indicator

The estimated number of patients in the United States with a condition for which the new prescription drug may be prescribed.

Estimated Number of Patients

Indicate whether the drug was granted breakthrough therapy designation by the federal Food and Drug Administration prior to approval.  An indicator of 1 means that this drug was reviewed as such prior to approval.

Breakthrough Therapy Indicator

Indicates whether the drug was granted priority review by the federal Food and Drug Administration prior to approval.  An indicator of 1 means that this drug was reviewed as such prior to approval.

Priority Review Indicator  

If the drug was not developed by the manufacturer:  The date the manufacturer acquired the drug.  A manufacturer may limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.

Acquisition Date  

If the drug was not developed by the manufacturer:  The price of acquisition.   A manufacturer may limit the information reported pursuant to subdivision (b) to that which is otherwise in the public domain or publicly available.

Q1-Q4 2019 Prescription Drugs Introduced to Market

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Data dictionary

API endpoint

Dataset Name