norepinephrine bitartrate

Product NDC
83634-307
11-digit product format
836340307
Labeler code
83634
Product ID
83634-307_2f29a14c-9f95-4661-aeef-aa0274023ba4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norepinephrine bitartrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Avenacy, LLC
Application
ANDA219924
Marketing category
ANDA
Marketing start
2026-02-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
norepinephrine bitartrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NOREPINEPHRINE BITARTRATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIFY5PE3ZRW
Rxcui242969

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ab36713-99a4-1d04-c42f-907afc73b6f9Product name720260105
209a4db0-2639-413d-9ad3-274ad7be11f7Product name120230912
08ddeef6-6d79-428b-a00b-432b50fc2b32Product name120230831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83634-307-04norepinephrine bitartrate10 in 1 CARTONINJECTION, SOLUTION101
83634-307-41norepinephrine bitartrate4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION41

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSNdd4b7827-2fe9-4427-a40a-60f275611bf41
2429694 ML norepinephrine 1 MG/ML InjectionSCDdd4b7827-2fe9-4427-a40a-60f275611bf41
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSYdd4b7827-2fe9-4427-a40a-60f275611bf41
242969norepinephrine 4 MG per 4 ML InjectionSYdd4b7827-2fe9-4427-a40a-60f275611bf41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83634-307-048363403070410 VIAL, SINGLE-DOSE in 1 CARTON (83634-307-04) / 4 mL in 1 VIAL, SINGLE-DOSE (83634-307-41) 2026-02-01NoNoCurrent
83634-307-41836340307414 mL in 1 VIAL, SINGLE-DOSE4 mlHistorical