Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII
Approved
Approval ID
3aa0b733-b58f-46bd-8e76-37ddf1dc3356
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 6, 2023
Manufacturers
FDA
Upsher-Smith Laboratories, LLC
DUNS: 079111820
Products 3
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
NDC Product Code0245-0410
Application NumberANDA206484
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 6, 2023
Generic NameHydrocodone Bitartrate and Acetaminophen
INGREDIENTS (9)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
Hydrocodone BitartrateActive
Quantity: 5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
AcetaminophenActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
Hydrocodone Bitartrate and Acetaminophen
PRODUCT DETAILS
NDC Product Code0245-0412
Application NumberANDA206484
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 6, 2023
Generic NameHydrocodone Bitartrate and Acetaminophen
INGREDIENTS (10)
AcetaminophenActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Hydrocodone BitartrateActive
Quantity: 10 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
Hydrocodone Bitartrate and Acetaminophen
PRODUCT DETAILS
NDC Product Code0245-0411
Application NumberANDA206484
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 6, 2023
Generic NameHydrocodone Bitartrate and Acetaminophen
INGREDIENTS (10)
Hydrocodone BitartrateActive
Quantity: 7.5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
AcetaminophenActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT