Hydromorphone Hydrochloride

Basic Information

Product Name

FDA Product Code

0406-3249

Regulatory Information

NDC Product Code

0406-3249

Application Number

ANDA076855

Marketing Category

C73584

Effective Date

March 15, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE TABLETS USP safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE TABLETS USP. HYDROMORPHONE HYDROCHLORIDE tablets USP, for oral use, CII Initial U.S. Approval: January 1984

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

HYDROMORPHONE HYDROCHLORIDE

Quantity: 8 mg in 1 1

Code: L960UP2KRW

Class Code: ACTIB

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

Active Moieties

HYDROMORPHONE

Code: Q812464R06

Basic Information

Regulatory Information

Company Information

Active Ingredients

LACTOSE MONOHYDRATE

MICROCRYSTALLINE CELLULOSE

MAGNESIUM STEARATE

STEARIC ACID

Active Moieties

HYDROMORPHONE