CLONIDINE HYDROCHLORIDE- clonidine hydrochloride tablet 
DirectRX

----------

CLONIDINE HYDROCHLORIDE

SPL Unclassified

Description

Clinical Pharmacology

Indications and Usage

Contraindications

Warnings

Precautions

Adverse Reactions

Overdosage

Dosage and Administration

How Supplied

Package Label

label

605-90

CLONIDINE HYDROCHLORIDE 
clonidine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-268(NDC:29300-137)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONIDINE HYDROCHLORIDE (UNII: W76I6XXF06) (CLONIDINE - UNII:MN3L5RMN02) CLONIDINE HYDROCHLORIDE 0.3 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
GLYCERIN (UNII: PDC6A3C0OX)  
POVIDONE K29/32 (UNII: 390RMW2PEQ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code U;137
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61919-268-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/29/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078895 12/29/2015
CLONIDINE HYDROCHLORIDE 
clonidine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-605(NDC:62332-054)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONIDINE HYDROCHLORIDE (UNII: W76I6XXF06) (CLONIDINE - UNII:MN3L5RMN02) CLONIDINE HYDROCHLORIDE 0.1 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
Color brown (Light Tan) Score 2 pieces
Shape OVAL (Oval,Biconvex) Size 7mm
Flavor Imprint Code L167
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61919-605-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/04/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091368 04/04/2019
Labeler - DirectRX (079254320)
Establishment
Name Address ID/FEI Business Operations
DirectRX 079254320 repack(61919-268, 61919-605)

Revised: 4/2019
Document Id: 85b86184-9fd6-2929-e053-2991aa0af846
Set id: 2823a922-3217-6062-e054-00144ff88e88
Version: 2
Effective Time: 20190404
 
DirectRX