MedPath

Alprazolam

Alprazolam Tablets, USP

Approved
Approval ID

0e6cb388-f5f4-40c7-add2-0d5375553805

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 28, 2013

Manufacturers
FDA

Blenheim Pharmacal, Inc.

DUNS: 171434587

Products 3

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

Alprazolam

PRODUCT DETAILS

NDC Product Code10544-029
Application NumberANDA074342
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 28, 2013
Generic NameAlprazolam

INGREDIENTS (8)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALPRAZOLAMActive
Quantity: 0.25 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Alprazolam

PRODUCT DETAILS

NDC Product Code10544-106
Application NumberANDA074342
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 28, 2013
Generic NameAlprazolam

INGREDIENTS (9)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ALPRAZOLAMActive
Quantity: 1 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT

Alprazolam

PRODUCT DETAILS

NDC Product Code10544-107
Application NumberANDA074342
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 28, 2013
Generic NameAlprazolam

INGREDIENTS (9)

ALPRAZOLAMActive
Quantity: 2 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT

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Alprazolam - FDA Drug Approval Details