Diazepam
Diazepam Oral Solution, CIV, 5 mg per 5 mL Diazepam Oral Solution (Concentrate), CIV, 25 mg per 5 mL (5 mg/mL) Rx Only
Approved
Approval ID
cdb839fb-27e5-4a11-aed6-da0a7ab6e996
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 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.
Diazepam Oral
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-767
Application NumberANDA206477
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diazepam Oral
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2023
FDA Product Classification
INGREDIENTS (10)
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIAZEPAMActive
Quantity: 5 mg in 5 mL
Code: Q3JTX2Q7TU
Classification: ACTIB
Diazepam Oral Solution (Concentrate)
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-768
Application NumberANDA204433
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diazepam Oral Solution (Concentrate)
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2023
FDA Product Classification
INGREDIENTS (7)
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCCINIC ACIDInactive
Code: AB6MNQ6J6L
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
DIAZEPAMActive
Quantity: 5 mg in 1 mL
Code: Q3JTX2Q7TU
Classification: ACTIB