Clonidine Hydrochloride (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 27241-108-06
60 Tablets
Clonidine Hydrochloride Extended-Release Tablets
0.1 mg
Pharmacist: Dispence the accompanying Patient Information leaflet to each patient.
Rx OnlyAjanta

0.1mg
(click image for full-size original)

CLONIDINE HYDROCHLORIDE clonidine hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27241-108
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
SODIUM LAURYL SULFATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE, UNSPECIFIED
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code CL
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27241-108-06 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209686 11/21/2017
Labeler — Ajanta Pharma USA Inc. (557554156)
Registrant — Ajanta Pharma Limited (918594859)
Establishment
Name Address ID/FEI Operations
Ajanta Pharma Limited 918594859 MANUFACTURE (27241-108)

Revised: 11/2021 Ajanta Pharma USA Inc.

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