68809-544 NDC - HEAVY DUTY HAND CLEANER ()

Drug Information

Product NDC: 68809-544
Proprietary Name: Heavy Duty Hand Cleaner
Non Proprietary Name:
Active Ingredient(s):
Administration Route(s):
Dosage Form(s):

Labeler Information

Field Name	Field Value
Labeler Name:	MPI Chemicals, Inc.
Product Type:
FDA Application Number:	M003
Marketing Category:	OTC MONOGRAPH DRUG
Start Marketing Date:	4/27/2004
End Marketing Date:	6/28/2023

Package Information

No.	Package Code	Package Description
1	68809-544-01	1200 mL in 1 CARTRIDGE (68809-544-01)
2	68809-544-03	350 mL in 1 CARTRIDGE (68809-544-03)
3	68809-544-05	540 mL in 1 BOTTLE, PLASTIC (68809-544-05)
4	68809-544-06	1 BAG in 1 BOX (68809-544-06) / 800 mL in 1 BAG
5	68809-544-07	700 mL in 1 BAG (68809-544-07)
6	68809-544-08	1 BAG in 1 BOX (68809-544-08) / 1000 mL in 1 BAG
7	68809-544-09	2000 mL in 1 CARTRIDGE (68809-544-09)
8	68809-544-10	1000 mL in 1 CARTRIDGE (68809-544-10)
9	68809-544-11	1000 mL in 1 BOTTLE, PLASTIC (68809-544-11)
10	68809-544-12	1000 mL in 1 BAG (68809-544-12)
11	68809-544-13	800 mL in 1 BAG (68809-544-13)
12	68809-544-14	3785 mL in 1 BOTTLE, PLASTIC (68809-544-14)
13	68809-544-15	946 mL in 1 BOTTLE, PLASTIC (68809-544-15)
14	68809-544-16	236 mL in 1 BOTTLE, PLASTIC (68809-544-16)
15	68809-544-17	532 mL in 1 BOTTLE, PLASTIC (68809-544-17)
16	68809-544-18	50 mL in 1 BOTTLE, PLASTIC (68809-544-18)
17	68809-544-19	18900 mL in 1 CONTAINER (68809-544-19)
18	68809-544-20	75600 mL in 1 DRUM (68809-544-20)
19	68809-544-24	118 mL in 1 BOTTLE, PLASTIC (68809-544-24)
20	68809-544-27	800 mL in 1 CARTRIDGE (68809-544-27)
21	68809-544-28	149 mL in 1 BOTTLE, PLASTIC (68809-544-28)
22	68809-544-35	132500 mL in 1 DRUM (68809-544-35)
23	68809-544-55	208200 mL in 1 DRUM (68809-544-55)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	68809-544	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	Heavy Duty Hand Cleaner	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	4/27/2004	This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE	6/28/2023	This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
MARKETING CATEGORY NAME	OTC MONOGRAPH DRUG	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	M003	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	MPI Chemicals, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.

68809-544 NDC - HEAVY DUTY HAND CLEANER ()

Drug Information

Labeler Information

Package Information

NDC Record

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