78819-100 NDC - HAND SANITIZER ()

Drug Information

Field Name	Field Value
Labeler Name:	THINH PHAT - KOREA SX TM XNK PHARMACEUTICAL COSMETICS COMPANY
Product Type:
FDA Application Number:	part333A
Marketing Category:	OTC MONOGRAPH NOT FINAL
Start Marketing Date:	3/30/2020

No.	Package Code	Package Description
1	78819-100-01	70 mL in 1 BOTTLE (78819-100-01)
2	78819-100-02	100 mL in 1 BOTTLE (78819-100-02)
3	78819-100-03	250 mL in 1 BOTTLE (78819-100-03)
4	78819-100-04	500 mL in 1 BOTTLE (78819-100-04)

Field Name	Field Value	Definition
PRODUCT NDC	78819-100	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.
PROPRIETARY NAME	Hand Sanitizer	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	3/30/2020	The translation of the dosage form Code submitted by the firm.
MARKETING CATEGORY NAME	OTC MONOGRAPH NOT FINAL	This is the date that the labeler indicates was the start of its marketing of the drug product.
APPLICATION NUMBER	part333A	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAME	THINH PHAT - KOREA SX TM XNK PHARMACEUTICAL COSMETICS COMPANY	Name of Company corresponding to the labeler code segment of the Product NDC.