FDA.reportPublic FDA data

Norepinephrine Bitartrate

Product NDC
71839-143
11-digit product format
718390143
Labeler code
71839
Product ID
71839-143_c42d425a-094e-4390-b4f9-4bb4b0fbc7d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norepinephrine bitartrate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
BE Pharmaceuticals Inc.
Application
ANDA217575
Marketing category
ANDA
Marketing start
2023-12-30
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
71839-143-01Norepinephrine Bitartrate4 mL in 1 VIAL, SINGLE-DOSEINJECTION41
71839-143-10Norepinephrine Bitartrate10 in 1 CARTONINJECTION101
71839-143-25Norepinephrine Bitartrate25 in 1 CARTONINJECTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71839-143-01ML - Milliliter71839-143d4783414-64e1-4c90-87a8-989a361712c812024-01-04
71839-143-25ML - Milliliter71839-14314855efe-711c-409e-8ced-11adca6e987312024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71839-143NOREPINEPHRINE BITARTRATE INJECTION [BE PHARMACEUTICALS INC.]1Current NDC, 3 package rows20231231_c42d425a-094e-4390-b4f9-4bb4b0fbc7d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSNc42d425a-094e-4390-b4f9-4bb4b0fbc7d01
2429694 ML norepinephrine 1 MG/ML InjectionSCDc42d425a-094e-4390-b4f9-4bb4b0fbc7d01
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSYc42d425a-094e-4390-b4f9-4bb4b0fbc7d01
242969norepinephrine 4 MG per 4 ML InjectionSYc42d425a-094e-4390-b4f9-4bb4b0fbc7d01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71839-143-01718390143014 mL in 1 VIAL, SINGLE-DOSE4 mlHistorical
71839-143-107183901431010 VIAL, SINGLE-DOSE in 1 CARTON (71839-143-10) / 4 mL in 1 VIAL, SINGLE-DOSE (71839-143-01) 2023-12-30NoNoCurrent
71839-143-257183901432525 VIAL, SINGLE-DOSE in 1 CARTON (71839-143-25) / 4 mL in 1 VIAL, SINGLE-DOSE (71839-143-01) 2023-12-30NoNoCurrent