Hydrocodone Polistirex and Chlorpheniramine Polistirex
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended Release Oral Suspension 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL(CIII)Rx only
Approved
Approval ID
3baf7498-5d7c-4163-9652-5445a019cd4b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 14, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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
NDC Product Code54868-6196
Application NumberANDA091632
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 4, 2010
Generic NameHydrocodone Polistirex and Chlorpheniramine Polistirex
INGREDIENTS (16)
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYDROCODONE BITARTRATEActive
Quantity: 10 mg in 5 mL
Code: NO70W886KK
Classification: ACTIB
CHLORPHENIRAMINE MALEATEActive
Quantity: 8 mg in 5 mL
Code: V1Q0O9OJ9Z
Classification: ACTIB
HIGH FRUCTOSE CORN SYRUPInactive
Code: XY6UN3QB6S
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359
Classification: IACT
WATERInactive
Code: 059QF0KO0R
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