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Oxycodone and Acetaminophen

OXYCODONE AND ACETAMINOPHEN TABLETS, USP 5 mg*/325 mg, 7.5 mg*/325 mg, 10 mg*/325 mg CII

Approved
Approval ID

f45e1078-f4ba-0317-e053-2995a90ab88d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 28, 2023

Manufacturers
FDA

NuCare Pharmaceuticals,Inc.

DUNS: 010632300

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Oxycodone and Acetaminophen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68071-2932
Application NumberANDA201278
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2023
FDA Product Classification

INGREDIENTS (9)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
OXYCODONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB

Drug Labeling Information

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 3/10/2021

HOW SUPPLIED

Oxycodone and Acetaminophen Tablets, USP is supplied as follows

5 mg/325 mg

White to off-white round biconvex tablet debossed 5 over 325 on one side and R bisect P on the other side.

Bottles of 4 tablets

NDC 68071-2932-4

Bottles of 12

NDC 68071-2932-2

Storage

Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP.

Store Oxycodone and Acetaminophen Tablets securely and dispose of properly [seePRECAUTIONS/Information for Patients/Caregivers] .

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Oxycodone and Acetaminophen - FDA Drug Approval Details