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Morphine Sulfate

Morphine Sulfate IR 15mg tabs

Approved
Approval ID

afd9129b-9d17-d002-e053-2a95a90a39ae

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 21, 2022

Manufacturers
FDA

RedPharm Drug, Inc.

DUNS: 828374897

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 Code67296-1753
Application NumberANDA210610
Product Classification
M
Marketing Category
C73584
G
Generic Name
morphine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2022
FDA Product Classification

INGREDIENTS (5)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MORPHINE SULFATEActive
Quantity: 15 mg in 1 1
Code: X3P646A2J0
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

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Morphine Sulfate - FDA Drug Approval Details