NDC 0310-4715

IV Solution Stabilizer

Iv Solution Stabilizer

IV Solution Stabilizer is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Polysorbate 80.

Product ID0310-4715_3c0aedca-0378-43ce-adcf-0b1caf0da3be
NDC0310-4715
Product TypeHuman Prescription Drug
Proprietary NameIV Solution Stabilizer
Generic NameIv Solution Stabilizer
Dosage FormSolution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-10-24
Marketing CategoryBLA / BLA
Application NumberBLA761104
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NamePOLYSORBATE 80
Active Ingredient Strength7 mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0310-4715-11

1 VIAL in 1 CARTON (0310-4715-11) > 1 mL in 1 VIAL
Marketing Start Date2018-10-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0310-4715-11 [00310471511]

IV Solution Stabilizer SOLUTION
Marketing CategoryBLA
Application NumberBLA761104
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-10-24

Drug Details

Active Ingredients

IngredientStrength
POLYSORBATE 806.5 mg/mL

OpenFDA Data

SPL SET ID:d6510282-1a57-4614-9859-299a227a089c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2099314
  • 2099309

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