FDA.reportPublic FDA data

NOREPINEPHRINE BITARTRATE

Product NDC
72572-481
11-digit product format
725720481
Labeler code
72572
Product ID
72572-481_c190b37f-ee4a-43ca-b9c6-dbe7a73771b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norepinephrine Bitartrate
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA211359
Marketing category
ANDA
Marketing start
2021-03-12
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
72572-481-01NOREPINEPHRINE BITARTRATE4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE44
72572-481-10NOREPINEPHRINE BITARTRATE10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-481NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE [CIVICA, INC.]4Current NDC, Legacy NDC, 2 package rows20230510_4408987e-690a-41ac-9677-e24604fa9793.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSN4408987e-690a-41ac-9677-e24604fa97934
2429694 ML norepinephrine 1 MG/ML InjectionSCD4408987e-690a-41ac-9677-e24604fa97934
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSY4408987e-690a-41ac-9677-e24604fa97934
242969norepinephrine 4 MG per 4 ML InjectionSY4408987e-690a-41ac-9677-e24604fa97934

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-481-01725720481014 mL in 1 VIAL, SINGLE-DOSE4 mlHistorical
72572-481-107257204811010 VIAL, SINGLE-DOSE in 1 CARTON (72572-481-10) / 4 mL in 1 VIAL, SINGLE-DOSE (72572-481-01) 2021-03-120000-00-00NoNoCurrent