Flurazepam Hydrochloride
Flurazepam Hydrochloride Capsules, USP These highlights do not include all the information needed to use FLURAZEPAM HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for FLURAZEPAM HYDROCHLORIDE CAPSULES. FLURAZEPAM HYDROCHLORIDE capsules, for oral use CIV Initial U.S. Approval: 1970
Approved
Approval ID
8f476891-1346-4e8c-ac1b-f8cbdc64f5a1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-736
Application NumberANDA072368
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flurazepam Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (19)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FLURAZEPAM HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: 756RDM536M
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
Flurazepam Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-737
Application NumberANDA072369
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flurazepam Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (19)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FLURAZEPAM HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 756RDM536M
Classification: ACTIB
SHELLACInactive
Code: 46N107B71O
Classification: IACT