Norepinephrine bitartrate

Product NDC
68083-437
11-digit product format
680830437
Labeler code
68083
Product ID
68083-437_5551d4eb-6e6f-4229-bd11-1442f685abe1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norepinephrine bitartrate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA214323
Marketing category
ANDA
Marketing start
2021-05-12
Substance
NOREPINEPHRINE BITARTRATE
Active strength
1 mg/mL
Pharmacologic classes
Catecholamine [EPC], Catecholamines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
IFY5PE3ZRWNOREPINEPHRINE BITARTRATE108341-18-0NOREPINEPHRINE BITARTRATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68083-437-106808304371010 VIAL, SINGLE-DOSE in 1 CARTON (68083-437-10) / 4 mL in 1 VIAL, SINGLE-DOSE (68083-437-01) 2021-05-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Norepinephrine bitartrateGland Pharma Limited2024-05-24Human Prescription Drug Label5