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FDA Drug information

Norepinephrine Bitartrate

Read time: 1 mins
Marketing start date: 26 Jan 2025
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Summary of product characteristics


Effective Time

20220726

Version

1

Spl Product Data Elements

Norepinephrine Bitartrate Norepinephrine Bitartrate NOREPINEPHRINE BITARTRATE NOREPINEPHRINE EDETATE DISODIUM SODIUM CHLORIDE SODIUM METABISULFITE WATER

Application Number

ANDA216341

Brand Name

Norepinephrine Bitartrate

Generic Name

Norepinephrine Bitartrate

Product Ndc

70771-1724

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1724-6 Norepinephrine Bitartrate Injection, USP 4 mg/4 mL (1 mg/mL) FOR INTRAVENOUS INFUSION ONLY. STERILE INJECTION Warning: This is potent drug. Dosage should be controlled by frequent determination of blood pressure. Do not leave patient unattended during administration. Avoid extravasation. Read package insert carefully. DILUTE BEFORE USE. DISCARD UNUSED PORTION. PROTECT FROM LIGHT. Warning: Contains Sulfites. 10 X 4 mL Single-Dose Vials Rx only NDC 70771-1724-1 Norepinephrine Bitartrate Injection, USP 4 mg/4 mL (1 mg/mL) FOR INTRAVENOUS INFUSION ONLY Warning: Contains Sulfites. DISCARD UNUSED PORTION. 4 mL Single-Dose Vial Rx only carton label vial label

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