Norepinephrine Bitartrate

Product NDC
0143-9318
11-digit product format
001439318
Labeler code
0143
Product ID
0143-9318_67c8be26-e727-4eac-b5a5-6c6fda27d2b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norepinephrine Bitartrate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA203662
Marketing category
ANDA
Marketing start
2018-08-01
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
0143-9318-01Norepinephrine Bitartrate4 mL in 1 VIALINJECTION45
0143-9318-10Norepinephrine Bitartrate10 in 1 CARTONINJECTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9318-01ML - Milliliter0143-9318fc8c801c-a007-4d5d-a944-256c96677e7e12019-02-13
0143-9318-10ML - Milliliter0143-93184065aadb-f76e-4c27-af31-6dc52b279d4512019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9318NOREPINEPHRINE BITARTRATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20250112_39cda6c6-3857-4028-80cf-aef135f8c7e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSN39cda6c6-3857-4028-80cf-aef135f8c7e65
2429694 ML norepinephrine 1 MG/ML InjectionSCD39cda6c6-3857-4028-80cf-aef135f8c7e65
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSY39cda6c6-3857-4028-80cf-aef135f8c7e65
242969norepinephrine 4 MG per 4 ML InjectionSY39cda6c6-3857-4028-80cf-aef135f8c7e65
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSNc90d875c-8e6e-284e-e053-2a95a90a334f3
2429694 ML norepinephrine 1 MG/ML InjectionSCDc90d875c-8e6e-284e-e053-2a95a90a334f3
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSYc90d875c-8e6e-284e-e053-2a95a90a334f3
242969norepinephrine 4 MG per 4 ML InjectionSYc90d875c-8e6e-284e-e053-2a95a90a334f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9318-01001439318014 mL in 1 VIAL4 mlHistorical
0143-9318-100014393181010 VIAL in 1 CARTON (0143-9318-10) / 4 mL in 1 VIAL (0143-9318-01) 10 vial2018-08-010000-00-00NoNoCurrent