MedPath

Oxycodone Hydrochloride

These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE Tablets, USP safely and effectively. See full prescribing information for Oxycodone Hydrochloride Tablets, USP. OXYCODONE HYDROCHLORIDE Tablets, USP, for oral use, CII Initial U.S. Approval: 1950

Approved
Approval ID

a5162476-1217-41c0-bc7e-0a0f123f069f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 19, 2024

Manufacturers
FDA

Rhodes Pharmaceuticals L.P.

DUNS: 831928986

Products 5

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

Oxycodone Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42858-001
Application NumberANDA091490
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2023
FDA Product Classification

INGREDIENTS (5)

Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Oxycodone HydrochlorideActive
Quantity: 5 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT

Oxycodone Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42858-003
Application NumberANDA091490
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2023
FDA Product Classification

INGREDIENTS (5)

Oxycodone HydrochlorideActive
Quantity: 15 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT

Oxycodone Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42858-005
Application NumberANDA091490
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2023
FDA Product Classification

INGREDIENTS (5)

Oxycodone HydrochlorideActive
Quantity: 30 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT

Oxycodone Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42858-002
Application NumberANDA091490
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2023
FDA Product Classification

INGREDIENTS (5)

Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Oxycodone HydrochlorideActive
Quantity: 10 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT

Oxycodone Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42858-004
Application NumberANDA091490
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2023
FDA Product Classification

INGREDIENTS (5)

Oxycodone HydrochlorideActive
Quantity: 20 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Oxycodone Hydrochloride - FDA Drug Approval Details