MedPath

Morphine Sulfate

These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate Tablets, CIIInitial U.S. Approval: 1984

Approved
Approval ID

67b3273e-af71-4dac-8e49-8bc134d4c591

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 8, 2013

Manufacturers
FDA

Dispensing Solutions, Inc.

DUNS: 066070785

Products 1

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

Morphine Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66336-502
Application NumberNDA022207
Product Classification
M
Marketing Category
C73594
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2013
FDA Product Classification

INGREDIENTS (5)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MORPHINE SULFATEActive
Quantity: 30 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Morphine Sulfate - FDA Drug Approval Details