NOREPINEPHRINE BITARTRATE

Product NDC
51662-1528
11-digit product format
516621528
Labeler code
51662
Product ID
51662-1528_0ff8ef97-006a-e6ca-e063-6294a90a2365
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NOREPINEPHRINE BITARTRATE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA203662
Marketing category
ANDA
Marketing start
2021-08-08
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
51662-1528-1NOREPINEPHRINE BITARTRATE4 mL in 1 VIALINJECTION43
51662-1528-2NOREPINEPHRINE BITARTRATE1 in 1 POUCHINJECTION13
51662-1528-2NOREPINEPHRINE BITARTRATE4 mL in 1 VIALINJECTION43
51662-1528-3NOREPINEPHRINE BITARTRATE10 in 1 CASEINJECTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1528NOREPINEPHRINE BITARTRATE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]3Current NDC, Legacy NDC, 4 package rows20240129_c90d875c-8e6e-284e-e053-2a95a90a334f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSNc90d875c-8e6e-284e-e053-2a95a90a334f3
2429694 ML norepinephrine 1 MG/ML InjectionSCDc90d875c-8e6e-284e-e053-2a95a90a334f3
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSYc90d875c-8e6e-284e-e053-2a95a90a334f3
242969norepinephrine 4 MG per 4 ML InjectionSYc90d875c-8e6e-284e-e053-2a95a90a334f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1528-1516621528014 mL in 1 VIAL (51662-1528-1) 4 ml2021-08-080000-00-00NoNoCurrent
51662-1528-2516621528021 in 1 POUCHHistorical
51662-1528-35166215280310 POUCH in 1 CASE (51662-1528-3) / 1 VIAL in 1 POUCH (51662-1528-2) / 4 mL in 1 VIAL10 pouch2022-07-100000-00-00NoNoCurrent