FDA.reportPublic FDA data

Norepinephrine Bitartrate

Product NDC
63323-940
11-digit product format
633230940
Labeler code
63323
Product ID
63323-940_c7fb762a-d42e-44a1-9c3a-af503aa96fb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NOREPINEPHRINE BITARTRATE
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA211382
Marketing category
ANDA
Marketing start
2021-03-01
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
63323-940-04Norepinephrine Bitartrate10 in 1 CARTONSOLUTION107
63323-940-21Norepinephrine Bitartrate4 mL in 1 VIAL, SINGLE-DOSESOLUTION47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-940-04ML - Milliliter63323-94059261f8f-5f67-43aa-b02c-816c1de210cc12021-08-05
63323-940-21ML - Milliliter63323-94018b7db3e-f217-4335-9691-7ff33592c7db12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-940NOREPINEPHRINE BITARTRATE SOLUTION [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 2 package rows20210908_c297757e-35ff-4f39-bccd-61002ac51e23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSNc297757e-35ff-4f39-bccd-61002ac51e237
2429694 ML norepinephrine 1 MG/ML InjectionSCDc297757e-35ff-4f39-bccd-61002ac51e237
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSYc297757e-35ff-4f39-bccd-61002ac51e237
242969norepinephrine 4 MG per 4 ML InjectionSYc297757e-35ff-4f39-bccd-61002ac51e237

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-940-046332309400410 VIAL, SINGLE-DOSE in 1 CARTON (63323-940-04) / 4 mL in 1 VIAL, SINGLE-DOSE (63323-940-21) 2021-03-010000-00-00NoNoCurrent
63323-940-21633230940214 mL in 1 VIAL, SINGLE-DOSE4 mlHistorical