78370-101 NDC - ANTIBACTERIAL FREE GEL ()

Drug Information

Product NDC: 78370-101
Proprietary Name: Antibacterial free gel
Non Proprietary Name:
Active Ingredient(s):
Administration Route(s):
Dosage Form(s):

Labeler Information

Field Name	Field Value
Labeler Name:	Guangzhou Xin Qi Cosmetics Co., Ltd.
Product Type:
FDA Application Number:	part333A
Marketing Category:	OTC MONOGRAPH NOT FINAL
Start Marketing Date:	3/30/2020

Package Information

No.	Package Code	Package Description
1	78370-101-01	60 mL in 1 BOTTLE (78370-101-01)
2	78370-101-02	80 mL in 1 BOTTLE (78370-101-02)
3	78370-101-03	100 mL in 1 BOTTLE (78370-101-03)
4	78370-101-04	200 mL in 1 BOTTLE (78370-101-04)
5	78370-101-05	250 mL in 1 BOTTLE (78370-101-05)
6	78370-101-06	300 mL in 1 BOTTLE (78370-101-06)
7	78370-101-07	500 mL in 1 BOTTLE (78370-101-07)
8	78370-101-08	1000 mL in 1 BOTTLE (78370-101-08)
9	78370-101-09	5000 mL in 1 BOTTLE (78370-101-09)
10	78370-101-10	10000 mL in 1 BOTTLE (78370-101-10)
11	78370-101-11	4000 mL in 1 BOTTLE (78370-101-11)
12	78370-101-12	2000 mL in 1 BOTTLE (78370-101-12)
13	78370-101-13	1500 mL in 1 BOTTLE (78370-101-13)
14	78370-101-14	236 mL in 1 BOTTLE (78370-101-14)
15	78370-101-15	240 mL in 1 BOTTLE (78370-101-15)
16	78370-101-16	30 mL in 1 BOTTLE (78370-101-16)
17	78370-101-17	3800 mL in 1 BOTTLE (78370-101-17)
18	78370-101-18	5 mL in 1 BOTTLE (78370-101-18)
19	78370-101-19	8 mL in 1 BOTTLE (78370-101-19)
20	78370-101-20	50 mL in 1 BOTTLE (78370-101-20)
21	78370-101-21	3 mL in 1 BOTTLE (78370-101-21)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	78370-101	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	Antibacterial free gel	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	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	OTC MONOGRAPH NOT FINAL	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.
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	Guangzhou Xin Qi Cosmetics Co., Ltd.	Name of Company corresponding to the labeler code segment of the Product NDC.

78370-101 NDC - ANTIBACTERIAL FREE GEL ()

Drug Information

Labeler Information

Package Information

NDC Record

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