Clonidine Hydrochloride Extended-Release (Page 7 of 7)

Package/Label Display Panel

NDC 10370-302-02
Clonidine Hydrochloride
Extended-Release Tablets
0.2 mg
60-count

Bottle-Label-0-2mg.jpg
(click image for full-size original)
CLONIDINE HYDROCHLORIDE EXTENDED-RELEASE
clonidine hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10370-257
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONIDINE HYDROCHLORIDE (CLONIDINE) CLONIDINE HYDROCHLORIDE 0.1 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE (TYPE E)
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code A257
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10370-257-02 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:10370-257-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:10370-257-13 180 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202984 09/30/2013
CLONIDINE HYDROCHLORIDE EXTENDED-RELEASE
clonidine hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10370-302
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONIDINE HYDROCHLORIDE (CLONIDINE) CLONIDINE HYDROCHLORIDE 0.2 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE (TYPE E)
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code A302
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10370-302-02 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:10370-302-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:10370-302-13 180 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202984 09/30/2013
Labeler — Par Pharmaceutical, Inc. (092733690)
Establishment
Name Address ID/FEI Operations
Anchen Pharmaceuticals, Inc. 122678886 ANALYSIS (10370-257), ANALYSIS (10370-302), MANUFACTURE (10370-257), MANUFACTURE (10370-302)

Revised: 09/2016 Par Pharmaceutical, Inc.

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