Norepinephrine Bitartrate

Product NDC
70121-1576
11-digit product format
701211576
Labeler code
70121
Product ID
70121-1576_0d4141ef-d701-496b-a84a-a4c49b3d0767
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norepinephrine Bitartrate
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA210839
Marketing category
ANDA
Marketing start
2018-12-17
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
70121-1576-1Norepinephrine Bitartrate4 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE47
70121-1576-7Norepinephrine Bitartrate10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1576-1ML - Milliliter70121-157624cf77c0-6732-40f0-a618-07e89c2bacf412019-07-02
70121-1576-7ML - Milliliter70121-1576b787ae4f-155f-4c5a-8a9b-48c1092dd49812019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1576NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE [AMNEAL PHARMACEUTICALS LLC]7Current NDC, Legacy NDC, 2 package rows20250427_256264b1-ddf6-42b7-8a09-194fffea65e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSN256264b1-ddf6-42b7-8a09-194fffea65e27
2429694 ML norepinephrine 1 MG/ML InjectionSCD256264b1-ddf6-42b7-8a09-194fffea65e27
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSY256264b1-ddf6-42b7-8a09-194fffea65e27
242969norepinephrine 4 MG per 4 ML InjectionSY256264b1-ddf6-42b7-8a09-194fffea65e27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1576-1701211576014 mL in 1 VIAL4 mlHistorical
70121-1576-77012115760710 VIAL in 1 CARTON (70121-1576-7) / 4 mL in 1 VIAL (70121-1576-1) 10 vial2018-12-170000-00-00NoNoCurrent