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Flurazepam Hydrochloride

Approved
Approval ID

347eb1a3-1957-4a4b-a0d5-1576adae3d13

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 3, 2013

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 2

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

flurazepam hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-0092
Application NumberANDA070345
Product Classification
M
Marketing Category
C73584
G
Generic Name
flurazepam hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2013
FDA Product Classification

INGREDIENTS (16)

FLURAZEPAM HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: 756RDM536M
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT

flurazepam hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-0093
Application NumberANDA070345
Product Classification
M
Marketing Category
C73584
G
Generic Name
flurazepam hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2013
FDA Product Classification

INGREDIENTS (16)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FLURAZEPAM HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 756RDM536M
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT

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Flurazepam Hydrochloride - FDA Drug Approval Details