Table of Contents: 2021 SEPTEMBER–OCTOBER No. 442
RxNorm October 2021 Monthly Release. NLM Tech Bull. 2021 Sep-Oct;(442):b10.
The RxNorm October monthly release became available for download on Monday, October 4, 2021. There are no major data changes in this release. However, information about Pfizer's COVID-19 vaccine is below.
No major changes.
FDA Approves First COVID-19 Vaccine
On August 23, 2021, Pfizer received FDA biologics license application (BLA) approval for its COVID-19 vaccine for use in individuals 16 and older, which will now be marketed as Comirnaty. At that time, the FDA published a BLA package insert that included the approved COVID-19 vaccine trade name, Comirnaty, and listed two new National Drug Codes (NDC: 0069-1000-03, 0069-1000-02) and images of labels with the new trade name.
At present, Pfizer does not plan to produce any product with these new NDCs and labels over the next few months while the emergency use authorized (EUA) product is still available and being made available for U.S. distribution. As such, the Centers for Disease Control and Prevention (CDC), American Medical Association (AMA), and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels.
