Oxycodone and Acetaminophen
Oxycodone and Acetaminophen Tablets, USP CII
Approved
Approval ID
205be197-5ad5-4849-bc78-5fda9927b531
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2022
Manufacturers
FDA
Mayne Pharma Inc.
DUNS: 867220261
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxycodone Hydrochloride and Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68308-475
Application NumberANDA090177
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone Hydrochloride and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2022
FDA Product Classification
INGREDIENTS (9)
Oxycodone HydrochlorideActive
Quantity: 7.5 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
AcetaminophenActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
crospovidone (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
Oxycodone Hydrochloride and Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68308-480
Application NumberANDA090177
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone Hydrochloride and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2022
FDA Product Classification
INGREDIENTS (9)
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
Oxycodone HydrochlorideActive
Quantity: 10 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
crospovidone (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
AcetaminophenActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT