oxycodone and acetaminophen
Oxycodone and Acetaminophen Tablets
Approved
Approval ID
88d97caf-bcf5-3cde-e053-2995a90acf4a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 27, 2023
Manufacturers
FDA
FH2 Pharma LLC
DUNS: 116969558
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
oxycodone and acetaminophen tablets
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72887-683
Application NumberANDA040608
Product Classification
M
Marketing Category
C73584
G
Generic Name
oxycodone and acetaminophen tablets
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2023
FDA Product Classification
INGREDIENTS (10)
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
oxycodone and acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72887-193
Application NumberANDA040608
Product Classification
M
Marketing Category
C73584
G
Generic Name
oxycodone and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2023
FDA Product Classification
INGREDIENTS (10)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
oxycodone and acetaminophen tablets
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72887-681
Application NumberANDA040608
Product Classification
M
Marketing Category
C73584
G
Generic Name
oxycodone and acetaminophen tablets
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2023
FDA Product Classification
INGREDIENTS (10)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
oxycodone and acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72887-682
Application NumberANDA040608
Product Classification
M
Marketing Category
C73584
G
Generic Name
oxycodone and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2023
FDA Product Classification
INGREDIENTS (10)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Drug Labeling Information
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 6/3/2019
INDICATIONS AND USAGE
Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [seeWARNINGS], reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non- opioid analgesics]
- Have not been tolerated, or are not expected to be tolerated,
- Have not provided adequate analgesia, or are not expected to provide adequate analgesia