NOREPINEPHRINE BITARTRATE (Page 3 of 3)
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis, mutagenesis, and fertility studies have not been performed.
16 HOW SUPPLIED/STORAGE AND HANDLING
Norepinephrine bitartrate injection, USP is a sterile, colorless solution for injection intended for intravenous use. It contains the equivalent of 1 mg of norepinephrine base per 1 mL (4 mg/4 mL). It is available as 4 mg/4 mL in single-dose amber glass vials.
Supplied as: 4 mg/4 mL Single-dose Vials in boxes of 10 (NDC 0781-3755-95)
Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
Store in original carton until time of administration to protect from light. Discard unused portion.
17 PATIENT COUNSELING INFORMATION
Risk of Tissue Damage
Advise the patient, family, or caregiver to report signs of extravasation urgently [see Warnings and Precautions ( 5.1)].
Distributed by
Sandoz Inc., Princeton, NJ 08540
46277218
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 0781-3755-95
Norepinephrine
Bitartrate Injection, USP
4mg/4mL* (1mg/mL)
FOR INTRAVENOUS INFUSION ONLY
Warning: Contains Sulfites.
Rx Only
10 x 4 mL Single-Dose Vials
SANDOZ – A Novartis Division
NOREPINEPHRINE BITARTRATE norepinephrine bitartrate injection, solution, concentrate | |||||||||||||||||
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Labeler — Sandoz Inc (005387188) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Delpharm Boucherville Canada Inc. | 242254227 | analysis (0781-3755), label (0781-3755), manufacture (0781-3755), pack (0781-3755), sterilize (0781-3755) |
Revised: 10/2022 Sandoz Inc
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