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CLONIDINE HYDROCHLORIDE

CLONIDINE HYDROCHLORIDE TABLETS USP

Approved
Approval ID

a756191e-085a-4a1a-bb88-b7c174cdcefd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 25, 2014

Manufacturers
FDA

Mutual Pharmaceutical Company, Inc.

DUNS: 121735955

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

clonidine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53489-215
Application NumberANDA070925
Product Classification
M
Marketing Category
C73584
G
Generic Name
clonidine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2014
FDA Product Classification

INGREDIENTS (8)

clonidine hydrochlorideActive
Quantity: 0.1 mg in 1 1
Code: W76I6XXF06
Classification: ACTIB
LactoseInactive
Code: J2B2A4N98G
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
D&C yellow no. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
aluminum oxideInactive
Code: LMI26O6933
Classification: IACT

clonidine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53489-217
Application NumberANDA070923
Product Classification
M
Marketing Category
C73584
G
Generic Name
clonidine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2014
FDA Product Classification

INGREDIENTS (9)

clonidine hydrochlorideActive
Quantity: 0.3 mg in 1 1
Code: W76I6XXF06
Classification: ACTIB
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT
D&C yellow no. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
aluminum oxideInactive
Code: LMI26O6933
Classification: IACT
FD&C blue no. 1Inactive
Code: H3R47K3TBD
Classification: IACT

clonidine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53489-216
Application NumberANDA070924
Product Classification
M
Marketing Category
C73584
G
Generic Name
clonidine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2014
FDA Product Classification

INGREDIENTS (6)

clonidine hydrochlorideActive
Quantity: 0.2 mg in 1 1
Code: W76I6XXF06
Classification: ACTIB
LactoseInactive
Code: J2B2A4N98G
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
sodium starch glycolate type A potatoInactive
Code: 5856J3G2A2
Classification: IACT

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CLONIDINE HYDROCHLORIDE - FDA Drug Approval Details