FDA.reportPublic FDA data

Norepinephrine bitartrate

Product NDC
67457-852
11-digit product format
674570852
Labeler code
67457
Product ID
67457-852_af3a6bd3-bbc9-43a9-a277-b55ae59d5097
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norepinephrine bitartrate
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA211242
Marketing category
ANDA
Marketing start
2018-10-15
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
67457-852-00Norepinephrine bitartrate4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE44
67457-852-04Norepinephrine bitartrate10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-852-00ML - Milliliter67457-852d9b628f3-8af7-4426-92b0-98a4aa653c4f12018-11-06
67457-852-04ML - Milliliter67457-852fe9fd43d-33a6-4976-b379-0b2cf64a651312018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-852NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE [MYLAN INSTITUTIONAL LLC]4Current NDC, Legacy NDC, 2 package rows20231129_d3ea12e0-88cc-49b0-b06e-5199ecd6ca69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSNd3ea12e0-88cc-49b0-b06e-5199ecd6ca694
2429694 ML norepinephrine 1 MG/ML InjectionSCDd3ea12e0-88cc-49b0-b06e-5199ecd6ca694
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSYd3ea12e0-88cc-49b0-b06e-5199ecd6ca694
242969norepinephrine 4 MG per 4 ML InjectionSYd3ea12e0-88cc-49b0-b06e-5199ecd6ca694

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-852-00674570852004 mL in 1 VIAL, SINGLE-DOSE4 mlHistorical
67457-852-046745708520410 VIAL, SINGLE-DOSE in 1 CARTON (67457-852-04) / 4 mL in 1 VIAL, SINGLE-DOSE (67457-852-00) 2018-10-150000-00-00NoNoCurrent