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Corphedra

These highlights do not include all the information needed to use CORPHEDRA safely and effectively. See full prescribing information for CORPHEDRA. CORPHEDRA (ephedrine sulfate injection, USP) for intravenous use Initial U.S. Approval: 2016

Approved
Approval ID

98531820-a85c-4ee7-9338-2be264219afe

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 17, 2018

Manufacturers
FDA

Par Pharmaceutical, Inc.

DUNS: 092733690

Products 2

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

ephedrine sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42023-233
Application NumberNDA208943
Product Classification
M
Marketing Category
C73594
G
Generic Name
ephedrine sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 14, 2021
FDA Product Classification

INGREDIENTS (1)

EPHEDRINE SULFATEActive
Quantity: 500 mg in 10 mL
Code: U6X61U5ZEG
Classification: ACTIB

Ephedrine Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42023-196
Application NumberNDA208943
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ephedrine Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 14, 2021
FDA Product Classification

INGREDIENTS (2)

EPHEDRINE SULFATEActive
Quantity: 50 mg in 1 mL
Code: U6X61U5ZEG
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Corphedra - FDA Drug Approval Details