Promethazine Hydrochloride
Promethazine Plain Oral Solution (Promethazine Hydrochloride Oral Solution)
Approved
Approval ID
7a186bcd-ab8c-4695-8289-4cd33bb551cf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2024
Manufacturers
FDA
PAI Holdings, LLC
DUNS: 044940096
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Promethazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0121-0927
Application NumberANDA040643
Product Classification
M
Marketing Category
C73584
G
Generic Name
Promethazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2024
FDA Product Classification
INGREDIENTS (17)
PROMETHAZINE HYDROCHLORIDEActive
Quantity: 6.25 mg in 5 mL
Code: R61ZEH7I1I
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT