Norepinephrine bitartrate

Product NDC
36000-162
11-digit product format
360000162
Labeler code
36000
Product ID
36000-162_73f5f4bb-09e2-4c5f-b482-c960bb957d53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norepinephrine bitartrate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA040859
Marketing category
ANDA
Marketing start
2012-04-01
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
36000-162-01Norepinephrine bitartrate04 mL in 1 AMPULEINJECTION0419
36000-162-10Norepinephrine bitartrate10 in 1 CARTONINJECTION1019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36000-162-01ML - Milliliter36000-162ede6f414-64c9-46b9-81c2-92a2bbc16e1a12014-10-03
36000-162-10ML - Milliliter36000-162f68516f2-53b5-4d62-8329-7d7d86bb4b5912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NOREPINEPHRINE BITARTRATEACTIVE INGREDIENTIFY5PE3ZRWNOREPINEPHRINE BITARTRATE INJECTION [CLARIS LIFESCIENCES INC.]7
NOREPINEPHRINEACTIVE MOIETYX4W3ENH1CVNOREPINEPHRINE BITARTRATE INJECTION [CLARIS LIFESCIENCES INC.]7
NITROGENINACTIVE INGREDIENTN762921K75NOREPINEPHRINE BITARTRATE INJECTION [CLARIS LIFESCIENCES INC.]7
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNOREPINEPHRINE BITARTRATE INJECTION [CLARIS LIFESCIENCES INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36000-162NOREPINEPHRINE BITARTRATE INJECTION [BAXTER HEALTHCARE CORPORATION]18Current NDC, Legacy NDC, 2 package rows20240621_a27fb6e0-8f7a-11db-9739-0050c2490048.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSNa27fb6e0-8f7a-11db-9739-0050c249004819
2429694 ML norepinephrine 1 MG/ML InjectionSCDa27fb6e0-8f7a-11db-9739-0050c249004819
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSYa27fb6e0-8f7a-11db-9739-0050c249004819
242969norepinephrine 4 MG per 4 ML InjectionSYa27fb6e0-8f7a-11db-9739-0050c249004819

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36000-162-013600001620104 mL in 1 AMPULE04 mlHistorical
36000-162-103600001621010 AMPULE in 1 CARTON (36000-162-10) / 4 mL in 1 AMPULE (36000-162-01) 10 ampule2012-04-010000-00-00NoNoCurrent