Norepinephrine Bitartrate

Manufacturer: Cantrell Drug Company
Effective date: 2015-03-06
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:20:24

Label at a glance#

ProductNorepinephrine Bitartrate

Active ingredientNorepinephrine Bitartrate

Label structure8 sections

Dosage and administration

FOR INTRAVENOUS USE ONLY. PRESERVATIVE-FREE INJECTION SOLUTION.

Storage and handling

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate.

Contacts and useful links#

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.gov

www.fda.gov/medwatch

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

• WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

Outsourced Compounded Drug. Not for Resale. Hospital/Office Use Only.

• ADVERSE EVENTS

ADVERSE REACTIONS SECTION

To facilitate Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088.

• HOW SUPPLIED

HOW SUPPLIED SECTION

Norepinephrine bitartrate injection solution is supplied as a sterile, nonpyrogenic solution that is clear, colorless at 250 mL in a Single-Dose Injection Solution Bag.

This product is Preservative-Free and Latex-Free.

• INGREDIENTS

DOSAGE FORMS & STRENGTHS SECTION

Each 1 mL contains the equivalent of 16 mcg norepinephrine base, 50 mg dextrose, 118.4 mcg sodium chloride, 32 mcg sodium metabisulfite, and pH adjusters include hydrochloric acid and/or sodium hydroxide, if necessary.

• STORAGE AND HANDLING

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit.

Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate.

• DOSAGE AND ADMINISTRATION.

DOSAGE & ADMINISTRATION SECTION

FOR INTRAVENOUS USE ONLY. PRESERVATIVE-FREE INJECTION SOLUTION.

SPL UNCLASSIFIED SECTION

Rx Only

Rev. 03/15

CANTRELL DRUG COMPANY
LITTLE ROCK, AR 72207

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
NOREPINEPHRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	Code 128	(01)00352533165184	GTIN-14: 00352533165184 GTIN-12: 352533165184 UPC-A: 352533165184 EAN-13: 0352533165184 GTIN storage (14 digits): 00352533165184	52533-165-18.jpg
Data code	Data Matrix	01003525332051251710		52533-165-18.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2ab36713-99a4-1d04-c42f-907afc73b6f9	Product name	7	20260105
209a4db0-2639-413d-9ad3-274ad7be11f7	Product name	1	20230912
08ddeef6-6d79-428b-a00b-432b50fc2b32	Product name	1	20230831
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52533-165-18	2020-01-31	C162847	48780-1	9d75b9d0-2dd0-f424-e053-dadaa90a57ce	Norepinephrine Bitartrate 4 mg Added to 5% Dextrose 250 mL Bag

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52533-165-18	Norepinephrine Bitartrate	250 mL in 1 BAG	INJECTION, SOLUTION	250		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52533-165	NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION [CANTRELL DRUG COMPANY]	1	Legacy NDC, 1 package rows	20150306_71f901b5-022b-43ea-b1a0-29adc9a1f718.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Norepinephrine Bitartrate	ACTIVE INGREDIENT	IFY5PE3ZRW	1
Norepinephrine	ACTIVE MOIETY	X4W3ENH1CV	1
ANHYDROUS DEXTROSE	INACTIVE INGREDIENT	5SL0G7R0OK	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	1
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Norepinephrine Bitartrate
Norepinephrine
ANHYDROUS DEXTROSE
SODIUM CHLORIDE
SODIUM METABISULFITE
WATER
HYDROCHLORIC ACID
SODIUM HYDROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52533-165	52533-165-18

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Norepinephrine Bitartrate	IFY5PE3ZRW	ACTIM
ANHYDROUS DEXTROSE	5SL0G7R0OK	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM METABISULFITE	4VON5FNS3C	IACT
WATER	059QF0KO0R	IACT
HYDROCHLORIC ACID	QTT17582CB	CNTM
SODIUM HYDROXIDE	55X04QC32I	CNTM

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 191 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTERIAL		278 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / EPIDURAL	0.05 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	0.68 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		24 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACARDIAC		70 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / INTRABURSAL	0.2 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INFILTRATION		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / TOPICAL	0.32 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SOLUTION / IONTOPHORESIS	0.05 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, FILM COATED / ORAL		100 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SUSPENSION / ORAL		40 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACAUDAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET / ORAL		231 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / PERINEURAL	0.05 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SOLUTION / ORAL		640 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SUSPENSION, EXTENDED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / SUBCUTANEOUS	0.7 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		2922 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GRANULE, FOR SUSPENSION / ORAL		162 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVITREAL	10 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / OPHTHALMIC		55 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
ANHYDROUS DEXTROSE	ANHYDROUS DEXTROSE	5SL0G7R0OK	SPRAY, METERED / NASAL		40 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SOLUTION / OPHTHALMIC	0.2 %w/w		Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / INTRAMUSCULAR	9 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / TOPICAL	3.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRATHECAL		9 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / AURICULAR (OTIC)	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CAPSULE, EXTENDED RELEASE / ORAL		41 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ENDOTRACHEAL	7.6 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / INFILTRATION	0.5 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / RETROBULBAR		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / ORAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBMUCOSAL	16 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	TABLET / SUBLINGUAL	2 mg		Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	TABLET / ORAL	8 mg		Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / OPHTHALMIC	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
ANHYDROUS DEXTROSE	ANHYDROUS DEXTROSE	5SL0G7R0OK	INJECTION, SOLUTION / INTRAVENOUS		3187 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	CAPSULE / ORAL	0.36 mg		Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SYSTEM / IONTOPHORESIS	0.5 mg		Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERINEURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / SUBCUTANEOUS		43 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAPERITONEAL	0.54 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	ENEMA / RECTAL	0.7 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	TABLET, CHEWABLE / ORAL	0.2 mg		Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / INTRAVENOUS	27.5 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SOLUTION / OPHTHALMIC	0.9 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	JELLY / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INFILTRATION		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CAPSULE / ORAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
ANHYDROUS DEXTROSE	ANHYDROUS DEXTROSE	5SL0G7R0OK	INJECTION / SUBCUTANEOUS	7.5 %w/v		Exact identifier — unii candidate 14 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / OPHTHALMIC		3 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / PERIDURAL	NA		Exact identifier — unii candidate 43 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e80698f9-c85c-43cf-a387-d9aa2d509a38			71f901b5-022b-43ea-b1a0-29adc9a1f718	2015-03-06	Warnings, Adverse reactions	Exact identifier spl id: e80698f9-c85c-43cf-a387-d9aa2d509a38 spl set id: 71f901b5-022b-43ea-b1a0-29adc9a1f718

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.