Clonidine Hydrochloride (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68180-606-06

Clonidine Hydrochloride Extended-Release Tablets

0.1 mg

Bottle of 30 tablets

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NDC 68180-606-07

Clonidine Hydrochloride Extended-Release Tablets

0.1 mg

Bottle of 60 tablets

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NDC 68180-606-09

Clonidine Hydrochloride Extended-Release Tablets

0.1 mg

Bottle of 90 tablets

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CLONIDINE HYDROCHLORIDE clonidine hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-606
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
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2208 (15000 MPA.S)
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE ((White to off white)) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code LU;Z55
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-606-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68180-606-07 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:68180-606-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209285 02/07/2018
Labeler — Lupin Pharmaceuticals, Inc. (089153071)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 650759348 MANUFACTURE (68180-606), PACK (68180-606)

Revised: 08/2020 Lupin Pharmaceuticals, Inc.

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