6% HETASTARCH IN 0.9% SODIUM CHLORIDE

Product NDC
51662-1317
11-digit product format
516621317
Labeler code
51662
Product ID
51662-1317_101e9d56-6d64-1bf0-e063-6394a90a22f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
6% HETASTARCH IN 0.9% SODIUM CHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
BA740193
Marketing category
ANDA
Marketing start
2018-11-26
Substance
HETASTARCH
Active strength
6 g/100mL
Pharmacologic classes
Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC], Starch [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
6% HETASTARCH IN 0.9% SODIUM CHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HETASTARCH6 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii875Y4127EA
Rxcui310757

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1317-16% HETASTARCH IN 0.9% SODIUM CHLORIDE500 mL in 1 CONTAINERINJECTION, SOLUTION5006
51662-1317-26% HETASTARCH IN 0.9% SODIUM CHLORIDE500 mL in 1 CONTAINERINJECTION, SOLUTION5006
51662-1317-36% HETASTARCH IN 0.9% SODIUM CHLORIDE12 in 1 CASEINJECTION, SOLUTION126

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-13176% HETASTARCH IN 0.9% SODIUM CHLORIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]6Current NDC, Legacy NDC, 3 package rows20240131_7b97c681-4514-c544-e053-2991aa0a3d78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310757hetastarch 6 % in 500 ML InjectionPSN7b97c681-4514-c544-e053-2991aa0a3d786
310757500 ML hetastarch 60 MG/ML InjectionSCD7b97c681-4514-c544-e053-2991aa0a3d786
310757hetastarch 6 % per 500 ML InjectionSY7b97c681-4514-c544-e053-2991aa0a3d786

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1317-151662131701500 mL in 1 CONTAINER (51662-1317-1) 500 ml2018-11-260000-00-00NoNoCurrent
51662-1317-251662131702500 mL in 1 CONTAINER500 mlHistorical
51662-1317-35166213170312 CONTAINER in 1 CASE (51662-1317-3) / 500 mL in 1 CONTAINER (51662-1317-2) 12 container2018-11-26NoNoHistorical