Hydrocodone Polistirex and Chlorpheniramine Polistirex
These highlights do not include all the information needed to use Hydrocodone Polistirex and Chlorpheniramine Polistirex safely and effectively. See full prescribing information for Hydrocodone Polistirex and Chlorpheniramine Polistirex. Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, for oral administration, CII Initial U.S. Approval: 1987
Approved
Approval ID
9445fb20-9601-44e8-ac08-b27e1e214755
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2023
Manufacturers
FDA
ATLANTIC BIOLOGICALS CORP.
DUNS: 047437707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocodone Polistirex and Chlorpheniramine Polistirex
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17856-0087
Application NumberANDA091632
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Polistirex and Chlorpheniramine Polistirex
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (18)
CHLORPHENIRAMINE MALEATEActive
Quantity: 8 mg in 5 mL
Code: V1Q0O9OJ9Z
Classification: ACTIB
HYDROCODONE BITARTRATEActive
Quantity: 10 mg in 5 mL
Code: NO70W886KK
Classification: ACTIB
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
POLYVINYL ACETATEInactive
Code: 32K497ZK2U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HIGH FRUCTOSE CORN SYRUPInactive
Code: XY6UN3QB6S
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
SODIUM POLYSTYRENE SULFONATEInactive
Code: 1699G8679Z
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT