FDA.reportPublic FDA data

NOREPINEPHRINE BITARTRATE

Product NDC
65145-133
11-digit product format
651450133
Labeler code
65145
Product ID
65145-133_9640013b-5019-476a-a35a-2a08084a2a3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norepinephrine bitartrate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Caplin Steriles Limited
Application
ANDA217575
Marketing category
ANDA
Marketing start
2024-09-28
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
65145-133-01NOREPINEPHRINE BITARTRATE4 mL in 1 VIAL, SINGLE-DOSEINJECTION42
65145-133-10NOREPINEPHRINE BITARTRATE10 in 1 CARTONINJECTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65145-133-01ML - Milliliter65145-1333c634101-f108-4de9-8376-d869a35ee15512024-10-04
65145-133-10ML - Milliliter65145-133fa1e5417-561c-4a53-8912-5409a86dce9d12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-133NOREPINEPHRINE BITARTRATE INJECTION [CAPLIN STERILES LIMITED]2Current NDC, 2 package rows20240929_2ffda6e7-d45d-4af3-a3b1-250a4c95e736.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242969norepinephrine bitartrate 4 MG in 4 mL InjectionPSN2ffda6e7-d45d-4af3-a3b1-250a4c95e7362
2429694 ML norepinephrine 1 MG/ML InjectionSCD2ffda6e7-d45d-4af3-a3b1-250a4c95e7362
242969norepinephrine (as bitartrate) 4 MG per 4 ML InjectionSY2ffda6e7-d45d-4af3-a3b1-250a4c95e7362
242969norepinephrine 4 MG per 4 ML InjectionSY2ffda6e7-d45d-4af3-a3b1-250a4c95e7362

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65145-133-01651450133014 mL in 1 VIAL, SINGLE-DOSE4 mlHistorical
65145-133-106514501331010 VIAL, SINGLE-DOSE in 1 CARTON (65145-133-10) / 4 mL in 1 VIAL, SINGLE-DOSE (65145-133-01) 2024-09-28NoNoHistorical