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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
875Y4127EAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310757Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7b97c681-4514-c544-e053-2991aa0a3d78Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hetastarch in Sodium ChlorideHETASTARCHHospira, Inc.d64f961a-3e1f-4b04-cf83-604474af27752026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BA740193
6% HETASTARCH IN 0.9% SODIUM CHLORIDE6% HETASTARCH IN 0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst7b97c681-4514-c544-e053-2991aa0a3d782024-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BA740193
ndc (product): 51662-1317

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 container2018-11-26NoNoCurrent