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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, for oral use CII Initial U.S. Approval: 1941

Approved
Approval ID

d66d0cfb-9bfe-490c-90ee-49481c567e85

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 29, 2023

Manufacturers
FDA

American Health Packaging

DUNS: 929561009

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 Code60687-617
Application NumberANDA212451
Product Classification
M
Marketing Category
C73584
G
Generic Name
Morphine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 29, 2023
FDA Product Classification

INGREDIENTS (6)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MORPHINE SULFATEActive
Quantity: 15 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

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Morphine Sulfate - FDA Drug Approval Details