Hydrocodone Bitartrate And Acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
Approved
Approval ID
0e7494b0-c061-49e8-bb02-3fd3bc960740
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 2
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 Code42254-100
Application NumberANDA089971
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate And Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJuly 27, 2011
FDA Product Classification
INGREDIENTS (6)
HYDROCODONE BITARTRATEActive
Quantity: 5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ACETAMINOPHENActive
Quantity: 500 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Hydrocodone Bitartrate And Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-079
Application NumberANDA040356
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate And Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJuly 27, 2011
FDA Product Classification
INGREDIENTS (12)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ACETAMINOPHENActive
Quantity: 500 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
HYDROCODONE BITARTRATEActive
Quantity: 10 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT