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OXYCODONE HYDROCHLORIDE

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

Approved
Approval ID

35bece72-ef61-4d11-a7e0-cea51dc12cc6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 26, 2021

Manufacturers
FDA

ATLANTIC BIOLOGICALS CORP.

DUNS: 047437707

Products 1

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 Code17856-0826
Application NumberANDA206822
Product Classification
M
Marketing Category
C73584
G
Generic Name
OXYCODONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2021
FDA Product Classification

INGREDIENTS (8)

SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 100 mg in 5 mL
Code: C1ENJ2TE6C
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT

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