Hydrocodone Bitartrate and Acetaminophen
Approved
Approval ID
f91a4c88-c083-45ab-8940-beaa9d9dcc24
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 28, 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 Bitartrate and Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4747
Application NumberANDA040182
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateOctober 28, 2010
FDA Product Classification
INGREDIENTS (12)
HYDROCODONE BITARTRATEActive
Quantity: 2.5 mg in 5 mL
Code: NO70W886KK
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
ACETAMINOPHENActive
Quantity: 167 mg in 5 mL
Code: 362O9ITL9D
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT