NDC 0781-3755

NOREPINEPHRINE BITARTRATE

Norepinephrine Bitartrate

NOREPINEPHRINE BITARTRATE is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Norepinephrine Bitartrate.

Product ID0781-3755_4f282cee-677a-4c16-823b-521adfc323fc
NDC0781-3755
Product TypeHuman Prescription Drug
Proprietary NameNOREPINEPHRINE BITARTRATE
Generic NameNorepinephrine Bitartrate
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-04-23
Marketing CategoryANDA / ANDA
Application NumberANDA211359
Labeler NameSandoz Inc
Substance NameNOREPINEPHRINE BITARTRATE
Active Ingredient Strength1 mg/mL
Pharm ClassesCatecholamine [EPC], Catecholamines [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0781-3755-95

10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3755-95) > 4 mL in 1 VIAL, SINGLE-DOSE (0781-3755-75)
Marketing Start Date2019-04-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-3755-95 [00781375595]

NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA211359
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-04-23

NDC 0781-3755-75 [00781375575]

NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA211359
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-04-23

Drug Details

Active Ingredients

IngredientStrength
NOREPINEPHRINE BITARTRATE1 mg/mL

OpenFDA Data

SPL SET ID:728734e7-1684-4b37-980c-f1dfd408b436
Manufacturer
UNII

Pharmacological Class

  • Catecholamine [EPC]
  • Catecholamines [CS]

NDC Crossover Matching brand name "NOREPINEPHRINE BITARTRATE" or generic name "Norepinephrine Bitartrate"

NDCBrand NameGeneric Name
0143-9318Norepinephrine BitartrateNorepinephrine Bitartrate
0338-0108NOREPINEPHRINE BITARTRATEnorepinephrine bitartrate
0338-0112NOREPINEPHRINE BITARTRATEnorepinephrine bitartrate
0703-1153Norepinephrine BitartrateNorepinephrine Bitartrate
0781-3755NOREPINEPHRINE BITARTRATENorepinephrine Bitartrate
25021-316Norepinephrine BitartrateNorepinephrine Bitartrate
36000-162Norepinephrine bitartrateNorepinephrine bitartrate
42023-245NOREPINEPHRINE BITARTRATENOREPINEPHRINE IN SODIUM CHLORIDE
42023-246NOREPINEPHRINE BITARTRATENOREPINEPHRINE in Sodium Chloride
42023-247NOREPINEPHRINE BITARTRATENorepinephrine in Sodium Chloride
43066-997Norepinephrine Bitartratenorepinephrine bitartrate
70121-1576Norepinephrine BitartrateNorepinephrine Bitartrate
52533-166Norepinephrine BitartrateNorepinephrine Bitartrate
52533-165Norepinephrine BitartrateNorepinephrine Bitartrate
52533-164Norepinephrine BitartrateNorepinephrine Bitartrate
67457-852Norepinephrine bitartrateNorepinephrine bitartrate
72078-002Norepinephrine bitartrateNorepinephrine bitartrate
0409-1443LevophedNorepinephrine bitartrate
0409-3375LEVOPHEDNOREPINEPHRINE BITARTRATE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.