61919-885 NDC - FLUOXETINE ()

Drug Information

No.	Package Code	Package Description	Billing Unit
1	61919-885-30	30 CAPSULE in 1 BOTTLE (61919-885-30)	EA
2	61919-885-90	90 CAPSULE in 1 BOTTLE (61919-885-90)	EA

Field Name	Field Value	Definition
PRODUCT NDC	61919-885	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME	FLUOXETINE	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE	8/1/2019	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	ANDA	The translation of the route code submitted by the firm, indicating route of administration.
APPLICATION NUMBER	ANDA078619	This is the date that the labeler indicates was the start of its marketing of the drug product.
LABELER NAME	Direct_Rx	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.