SYMJEPI

Product NDC
0781-3448
11-digit product format
007813448
Labeler code
0781
Product ID
0781-3448_683751b5-3deb-4292-b7e8-96f68bd09f0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Epinephrine
Dosage form
INJECTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Sandoz Inc.
Application
NDA207534
Marketing category
NDA
Marketing start
2019-02-01
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3448-20EA - Each0781-344834986327-5589-4365-b772-193bd51d7e9912019-08-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-3448-20007813448202 SYRINGE in 1 CARTON (0781-3448-20) > .3 mL in 1 SYRINGE2 syringe2019-02-012021-05-31NoNoCurrent