FDA.reportPublic FDA data

NOREPINEPHRINE BITARTRATE

Product NDC
0781-3755
11-digit product format
007813755
Labeler code
0781
Product ID
0781-3755_eaf2eebc-d694-f15a-e053-2995a90a81b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norepinephrine Bitartrate
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA211359
Marketing category
ANDA
Marketing start
2019-04-23
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
0781-3755-75NOREPINEPHRINE BITARTRATE4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE410
0781-3755-95NOREPINEPHRINE BITARTRATE10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3755-75ML - Milliliter0781-37550f3d1a22-562d-4ba3-a51f-e4d4af42d25a12019-07-02
0781-3755-95ML - Milliliter0781-3755cd1a2664-8b3c-4a5e-b809-3ebecfe3c87d12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3755NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE [SANDOZ INC]10Current NDC, Legacy NDC, 2 package rows20221014_728734e7-1684-4b37-980c-f1dfd408b436.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSN728734e7-1684-4b37-980c-f1dfd408b43610
2429694 ML norepinephrine 1 MG/ML InjectionSCD728734e7-1684-4b37-980c-f1dfd408b43610
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSY728734e7-1684-4b37-980c-f1dfd408b43610
242969norepinephrine 4 MG per 4 ML InjectionSY728734e7-1684-4b37-980c-f1dfd408b43610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-3755-75007813755754 mL in 1 VIAL, SINGLE-DOSE4 mlHistorical
0781-3755-950078137559510 VIAL, SINGLE-DOSE in 1 CARTON (0781-3755-95) / 4 mL in 1 VIAL, SINGLE-DOSE (0781-3755-75) 2019-04-230000-00-00NoNoCurrent