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NDC 72850-0004-01 Stozyme 5.21; 5.21; 10.42; 36.46 1/1001; 1/1001; 1/1001; 1/1001 Details

Stozyme 5.21; 5.21; 10.42; 36.46 1/1001; 1/1001; 1/1001; 1/1001

Stozyme is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Chunwoo Pharmaceutical Co., Ltd.. The primary component is BOS TAURUS BILE; DIMETHICONE; HEMICELLULASE (ASPERGILLUS NIGER); PANCRELIPASE.

Product Information

NDC	72850-0004
Product ID	72850-0004_96932453-80c3-4a44-e053-2a95a90a7bb6
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Stozyme
Proprietary Name Suffix	n/a
Non-Proprietary Name	pancreatin, hemicellulase, OX bile extract, dimethicone
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	5.21; 5.21; 10.42; 36.46
Active Ingredient Units	1/1001; 1/1001; 1/1001; 1/1001
Substance Name	BOS TAURUS BILE; DIMETHICONE; HEMICELLULASE (ASPERGILLUS NIGER); PANCRELIPASE
Labeler Name	Chunwoo Pharmaceutical Co., Ltd.
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2022-12-31

Package

Package Images

NDC 72850-0004-01 (72850000401)

Pricing Information	N/A
NDC Package Code	72850-0004-1
Billing NDC	72850000401
Package	10 TABLET in 1 BLISTER PACK (72850-0004-1)
Marketing Start Date	2019-10-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 96932453-80c2-4a44-e053-2a95a90a7bb6 Details

ACTIVE INGREDIENT

Pancreatin 36.46%

Hemicellulase 10.42%

Ox Bile Extract 5.21%

Dimethicone 5.21%

INACTIVE INGREDIENT

Food Blue No. 1, Food Yellow No. 4, Colloidal Silicon Dioxide, Microcrystalline Cellulose, Low-Substituted Hydroxypropyl Cellulose, Magnesium Stearate, Hypromellose Phthalate, Glyceryl Monostearate, Castor Oil, Hypromellose 2910, Titanium Oxide, Polyethylene Glycol 6000,

PURPOSE

Anorexia, overeating, and abdominal distention

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

WARNING

Do not take if

-you have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. This medicine contains lactose (sugar) carbohydrates.

-you are under 5

Ask doctor before taking if

- you are on other medication

- you are hypersensitive or have history of allergic response to Tartazine

Keep the proper usage and volume

Stop use and ask a doctor if

- If there is no improvement in the irradiation after 2 weeks of taking the medicine

USES

for oral use only

INDICATION & USAGE SECTION

Treats anorexia, overeating, and abdominal distention

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STOZYME

pancreatin, hemicellulase, ox bile extract, dimethicone tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72850-0004
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HEMICELLULASE (ASPERGILLUS NIGER) (UNII: S2MZZ5DR1O) (HEMICELLULASE (ASPERGILLUS NIGER) - UNII:S2MZZ5DR1O)	HEMICELLULASE (ASPERGILLUS NIGER)	10.42 in 100
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	5.21 in 100
PANCRELIPASE (UNII: FQ3DRG0N5K) (PANCRELIPASE LIPASE - UNII:8MYC33932O)	PANCRELIPASE LIPASE	36.46 in 100
BOS TAURUS BILE (UNII: ET3651ZLOU) (BOS TAURUS BILE - UNII:ET3651ZLOU)	BOS TAURUS BILE	5.21 in 100

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72850-0004-1	10 in 1 BLISTER PACK; Type 0: Not a Combination Product	10/19/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		10/19/2019

Labeler - Chunwoo Pharmaceutical Co., Ltd. (688729065)

Registrant - Chunwoo Pharmaceutical Co., Ltd. (688729065)

Name	Address	ID/FEI	Business Operations
Establishment
Chunwoo Pharmaceutical Co., Ltd.		688729065	manufacture(72850-0004)

Revised: 11/2019

Document Id: 96932453-80c3-4a44-e053-2a95a90a7bb6

Set id: 96932453-80c2-4a44-e053-2a95a90a7bb6

Version: 1

Effective Time: 20191104