Symjepi

Product NDC
78670-131
11-digit product format
786700131
Labeler code
78670
Product ID
78670-131_b81ff52b-5ce1-4794-8ac6-8195e6360f9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
epinephrine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
USWM, LLC
Application
NDA207534
Marketing category
NDA
Marketing start
2020-11-01
Marketing end
0000-00-00
Substance
EPINEPHRINE
Active strength
0 mg/.3mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78670-131-02786700131022 SYRINGE in 1 CARTON (78670-131-02) > .3 mL in 1 SYRINGE (78670-131-11) 2 syringe2020-11-010000-00-00NoNoCurrent