Hycet
Hycet hydrocodone bitartrate and acetaminophen oral solution7.5 mg/325 mg per 15 mL Rx only
Approved
Approval ID
47df0152-b0a7-d03a-01e5-b9e22c3533c8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 15, 2014
Manufacturers
FDA
G&W Laboratories, Inc.
DUNS: 001271188
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 Code0713-0703
Application NumberANDA040482
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone bitartrate and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateDecember 17, 2014
FDA Product Classification
INGREDIENTS (14)
Hydrocodone BitartrateActive
Quantity: 7.5 mg in 15 mL
Code: NO70W886KK
Classification: ACTIB
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
AcetaminophenActive
Quantity: 325 mg in 15 mL
Code: 362O9ITL9D
Classification: ACTIB
Ethyl MaltolInactive
Code: L6Q8K29L05
Classification: IACT
MethylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
Saccharin Sodium DihydrateInactive
Code: SB8ZUX40TY
Classification: IACT
PropylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
SorbitolInactive
Code: 506T60A25R
Classification: IACT
D&c Red No. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
Fd&c Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
Anhydrous Citric AcidInactive
Code: XF417D3PSL
Classification: IACT