epinephrine

Product NDC
68083-591
11-digit product format
680830591
Labeler code
68083
Product ID
68083-591_53173df9-7a0c-4eb2-8103-8e6405bc1e7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
epinephrine
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAMUSCULAR; INTRAOCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Gland Pharma Limited
Application
ANDA218144
Marketing category
ANDA
Marketing start
2025-06-03
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-591-106808305911010 AMPULE in 1 BOX (68083-591-10) / 1 mL in 1 AMPULE10 ampule2025-06-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
epinephrineGland Pharma Limited2025-06-03Human Prescription Drug Label3