FDA.reportPublic FDA data

Norepinephrine Bitartrate

Product NDC
43066-997
11-digit product format
430660997
Labeler code
43066
Product ID
43066-997_8447ca70-d877-4a4e-9316-679bdaca28d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norepinephrine bitartrate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Company
Application
ANDA214323
Marketing category
ANDA
Marketing start
2021-05-06
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
43066-997-01Norepinephrine Bitartrate4 mL in 1 VIAL, SINGLE-DOSEINJECTION45
43066-997-10Norepinephrine Bitartrate10 in 1 CARTONINJECTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43066-997-01ML - Milliliter43066-997b795342c-d8eb-4124-8b63-51b09fe5884812022-07-06
43066-997-10ML - Milliliter43066-99755741bcd-c54a-4134-9ced-1dc6db9f5cfd12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43066-997NOREPINEPHRINE BITARTRATE INJECTION [BAXTER HEALTHCARE COMPANY]5Current NDC, Legacy NDC, 2 package rows20250514_e375a0b9-4d26-4749-bbc3-43d63a7cf65a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSNe375a0b9-4d26-4749-bbc3-43d63a7cf65a5
2429694 ML norepinephrine 1 MG/ML InjectionSCDe375a0b9-4d26-4749-bbc3-43d63a7cf65a5
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSYe375a0b9-4d26-4749-bbc3-43d63a7cf65a5
242969norepinephrine 4 MG per 4 ML InjectionSYe375a0b9-4d26-4749-bbc3-43d63a7cf65a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43066-997-01430660997014 mL in 1 VIAL, SINGLE-DOSE4 mlHistorical
43066-997-104306609971010 VIAL, SINGLE-DOSE in 1 CARTON (43066-997-10) / 4 mL in 1 VIAL, SINGLE-DOSE (43066-997-01) 2021-05-060000-00-00NoNoCurrent