Clonidine Hydrochloride (Page 3 of 3)

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature]

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Address medical inquiries to: 1-888-351-3786.

Manufactured by:
MUTUAL PHARMACEUTICAL COMPANY, INC.
Philadelphia, PA 19124 USA

Rev 03, April 2010

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146

PRINCIPAL DISPLAY PANEL — 0.1 mg Bottle Label

CLONIDINE HYDROCHLORIDE TABLETS USP

0.1 mg

Rx only

Principal Display Panel -- 0.1 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.2 mg Bottle Label

CLONIDINE HYDROCHLORIDE TABLETS USP

0.2 mg

Rx only

Principal Display Panel -- 0.2 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.3 mg Bottle Label

CLONIDINE HYDROCHLORIDE TABLETS USP

0.3 mg

Rx only

Principal Display Panel -- 0.3 mg Bottle Label
(click image for full-size original)
CLONIDINE HYDROCHLORIDE clonidine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-0048(NDC:53489-215)
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
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
D&C YELLOW NO. 10
Product Characteristics
Color yellow Score no score
Shape ROUND Size 7mm
Flavor Imprint Code MP;657
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-0048-1 20 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-0048-2 60 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-0048-3 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:54868-0048-5 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
5 NDC:54868-0048-7 15 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
6 NDC:54868-0048-8 90 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070925 10/03/2001
CLONIDINE HYDROCHLORIDE clonidine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-0049(NDC:53489-216)
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
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code MP;658
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-0049-1 90 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-0049-2 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-0049-5 60 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:54868-0049-6 120 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
5 NDC:54868-0049-7 180 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070924 01/09/1995
CLONIDINE HYDROCHLORIDE clonidine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-1967(NDC:53489-217)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONIDINE HYDROCHLORIDE (CLONIDINE) CLONIDINE HYDROCHLORIDE 0.3 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
D&C YELLOW NO. 10
FD&C BLUE NO. 1
Product Characteristics
Color green Score no score
Shape ROUND Size 7mm
Flavor Imprint Code MP;659
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-1967-0 60 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-1967-2 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-1967-3 90 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:54868-1967-4 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
5 NDC:54868-1967-1 120 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070923 11/30/2004
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 06/2012 Physicians Total Care, Inc.

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