NOREPINEPHRINE BITARTRATE (Page 3 of 3)

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 72572-481-10)

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)].

Mfd for: Civica, Inc., Lehi, UT 84043

Mfd by: Sandoz Manufacturing Inc.

145 rue Jules-Léger

Boucherville, Québec, J4B 7K8

46270872

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 72572-481-10

Norepinephrine

Bitartrate Injection, USP

4mg/4mL* (1mg/mL)

FOR INTRAVENOUS INFUSION ONLY

Warning: Contains Sulfites.

Rx Only

10 x 4 mL Single-Dose Vials

CIVICA

carton
(click image for full-size original)
NOREPINEPHRINE BITARTRATE
norepinephrine bitartrate injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72572-481
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NOREPINEPHRINE BITARTRATE (NOREPINEPHRINE) NOREPINEPHRINE 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM METABISULFITE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72572-481-10 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (72572-481-01)
1 NDC:72572-481-01 4 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (72572-481-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211359 03/12/2021
Labeler — Civica, Inc. (081373942)

Revised: 03/2022 Civica, Inc.

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