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NDC 24357-0011-13 Epinephrine Professional Details

Epinephrine Professional

Epinephrine Professional is a INTRAMUSCULAR; SUBCUTANEOUS KIT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Focus Health Group. The primary component is .

MedlinePlus Drug Summary

Epinephrine injection is used along with emergency medical treatment to treat life-threatening allergic reactions caused by insect bites or stings, foods, medications, latex, and other causes. Epinephrine is in a class of medications called alpha- and beta-adrenergic agonists (sympathomimetic agents). It works by relaxing the muscles in the airways and tightening the blood vessels.

Related Packages: 24357-0011-13
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Epinephrine Injection

Product Information

NDC	24357-0011
Product ID	24357-011_eb6598c3-bb08-32e0-e053-2a95a90a13b5
Associated GPIs	38900040006420
GCN Sequence Number	074866
GCN Sequence Number Description	epinephrine KIT 1 MG/ML(1) INJECTION
HIC3	J5F
HIC3 Description	ANAPHYLAXIS THERAPY AGENTS
GCN	39693
HICL Sequence Number	002050
HICL Sequence Number Description	EPINEPHRINE
Brand/Generic	Brand
Proprietary Name	Epinephrine Professional
Proprietary Name Suffix	n/a
Non-Proprietary Name	Epinephrine and Isopropyl Alcohol
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	KIT
Route	INTRAMUSCULAR; SUBCUTANEOUS
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Focus Health Group
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA204200
Listing Certified Through	2023-12-31

Package

Package Images

NDC 24357-0011-13 (24357001113)

Pricing Information	N/A
NDC Package Code	24357-011-13
Billing NDC	24357001113
Package	1 KIT in 1 CARTON (24357-011-13) * 1 mL in 1 VIAL (42023-159-25) * 1 mL in 1 PACKET (68599-5804-1)
Marketing Start Date	2019-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8c502fcc-1b61-7d1f-e053-2a95a90adc46 Details

SPL UNCLASSIFIED SECTION

For treating anaphylaxis:

Adults and Children 30 kg (66 lbs) or more: 0.3 to 0.5 mg (0.3 to 0.5 ml) intramuscularly or subcutaneously into anterolateral aspect of the thigh every 5 to 10 minutes as necessary.

Children 30 kg (66 lbs) or less: 0.01 mg/kg (0.01 ml/kg), up to 0.3 mg (0.3 ml), intramuscularly or subcutaneously into anterolateral aspect of the thigh every 5 to 10 minutes as necessary.

Principal Display Panel

INGREDIENTS AND APPEARANCE

EPINEPHRINE PROFESSIONAL

epinephrine and isopropyl alcohol kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:24357-011

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24357-011-13	1 in 1 CARTON; Type 0: Not a Combination Product	07/01/2019

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 VIAL	1 mL
Part 2	4 PACKET	4 mL

Part 1 of 2
ADRENALIN epinephrine injection

Product Information
Item Code (Source)	NDC:42023-159
Route of Administration	INTRAMUSCULAR, SUBCUTANEOUS, INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
TARTARIC ACID (UNII: W4888I119H)	2.25 mg in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)	1 mg in 1 mL
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.2 mg in 1 mL
SODIUM METABISULFITE (UNII: 4VON5FNS3C)	0.457 mg in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	7.3 mg in 1 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42023-159-25	1 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA204200	07/01/2013

Part 2 of 2
MCKESSON ALCOHOL PREP PAD isopropyl alcohol swab

Product Information
Item Code (Source)	NDC:68599-5804
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68599-5804-1	1 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/09/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA204200	07/01/2019

Labeler - Focus Health Group (826939949)

Name	Address	ID/FEI	Business Operations
Establishment
Par Sterile Products LLC		808402890	manufacture(42023-159)

Name	Address	ID/FEI	Business Operations
Establishment
Focus Health Group		826939949	manufacture(24357-011)

Revised: 10/2022

Document Id: eb6598c3-bb08-32e0-e053-2a95a90a13b5

Set id: 8c502fcc-1b61-7d1f-e053-2a95a90adc46

Version: 5

Effective Time: 20221019