FDA.reportPublic FDA data

Norepinephrine Bitartrate

Product NDC
71288-439
11-digit product format
712880439
Labeler code
71288
Product ID
71288-439_48ca273a-3c9d-4466-8804-a0a24790d379
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norepinephrine Bitartrate
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA040455
Marketing category
ANDA
Marketing start
2024-12-01
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
71288-439-04Norepinephrine Bitartrate4 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION, CONCENTRATE42
71288-439-05Norepinephrine Bitartrate10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-439-04ML - Milliliter71288-439bb1e7445-0d5f-4f52-a7be-b4dd10cc5e2112025-05-14
71288-439-05ML - Milliliter71288-4397aa0cc2e-c4b9-416b-85ef-84f1f3b16b6512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-439NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE [MEITHEAL PHARMACEUTICALS INC.]2Current NDC, 2 package rows20241202_53578ac5-b510-4698-a097-f785bfea9fc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSN53578ac5-b510-4698-a097-f785bfea9fc02
2429694 ML norepinephrine 1 MG/ML InjectionSCD53578ac5-b510-4698-a097-f785bfea9fc02
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSY53578ac5-b510-4698-a097-f785bfea9fc02
242969norepinephrine 4 MG per 4 ML InjectionSY53578ac5-b510-4698-a097-f785bfea9fc02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71288-439-04712880439044 mL in 1 VIAL, SINGLE-USE4 mlHistorical
71288-439-057128804390510 VIAL, SINGLE-USE in 1 CARTON (71288-439-05) / 4 mL in 1 VIAL, SINGLE-USE (71288-439-04) 2024-12-01NoNoHistorical