Prometh with Codeine
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP CV FORM NO. 1627 Rev. 1/09 VC3276 Rx Only
Approved
Approval ID
a4fd8978-2036-43cb-ab16-b0dd98d6cd5b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2012
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Promethazine Hydrochloride and Codeine Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-140
Application NumberANDA088763
Product Classification
M
Marketing Category
C73584
G
Generic Name
Promethazine Hydrochloride and Codeine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2009
FDA Product Classification
INGREDIENTS (14)
Codeine PhosphateActive
Quantity: 10 mg in 5 mL
Code: GSL05Y1MN6
Classification: ACTIB
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
Promethazine HydrochlorideActive
Quantity: 6.25 mg in 5 mL
Code: R61ZEH7I1I
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
corn syrupInactive
Code: 9G5L16BK6N
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
SACCHARIN SODIUM DIHYDRATEInactive
Code: SB8ZUX40TY
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
sodium citrateInactive
Code: 1Q73Q2JULR
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT