EPINEPHRINE

Product NDC
63323-696
11-digit product format
633230696
Labeler code
63323
Product ID
63323-696_e61f344b-7215-425c-9767-fd4210748221
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EPINEPHRINE
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAMUSCULAR; INTRAOCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA213708
Marketing category
ANDA
Marketing start
2024-11-21
Substance
EPINEPHRINE
Active strength
1 mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
YKH834O4BHEPINEPHRINE51-43-4EPINEPHRINE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63323-696-256332306962525 VIAL, SINGLE-DOSE in 1 TRAY (63323-696-25) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-696-02) 2024-11-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
EPINEPHRINEREMEDYREPACK INC.2025-06-30HUMAN PRESCRIPTION DRUG LABEL2
EPINEPHRINEFresenius Kabi USA, LLC2024-12-06HUMAN PRESCRIPTION DRUG LABEL1