FDA.reportPublic FDA data

Hydroxyethyl Starch in Sodium Chloride

Product NDC
0264-1968
Requested package NDC
0264-1968-10
11-digit product format
002641968
Labeler code
0264
Product ID
0264-1968_cd814120-e760-4719-b3a6-fa1d180ac269
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyethyl Starch in Sodium Chloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
BA110013
Marketing category
ANDA
Marketing start
2015-01-09
Marketing end
0000-00-00
Substance
HYDROXYETHYL STARCH 130/0.4; SODIUM CHLORIDE
Active strength
6 g/100mL; mg/100mL
Pharmacologic classes
Plasma Volume Expander [EPC],Increased Intravascular Volume [PE],Osmotic Activity [MoA],Starch [CS],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0264-19680264-1968-10DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10EExcluded after deficient or non-compliant submission was not corrected9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0264-1968-102020-03-10C16284748780-19d75b9d0-5968-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection safely and effectively. See full prescribing information for 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection . 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection For administration by intravenous infusion Initial U.S. Approval: 2007
0264-1968-102020-01-31C16284748780-19d75b9d0-5968-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection safely and effectively. See full prescribing information for 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection . 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection For administration by intravenous infusion Initial U.S. Approval: 2007

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYETHYL STARCH 130/0.4ACTIVE INGREDIENT1GVO236S58HYDROXYETHYL STARCH IN SODIUM CHLORIDE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]7
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XHYDROXYETHYL STARCH IN SODIUM CHLORIDE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]7
CHLORIDE IONACTIVE MOIETYQ32ZN48698HYDROXYETHYL STARCH IN SODIUM CHLORIDE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]7
HYDROXYETHYL STARCH 130/0.4ACTIVE MOIETY1GVO236S58HYDROXYETHYL STARCH IN SODIUM CHLORIDE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]7
WATERINACTIVE INGREDIENT059QF0KO0RHYDROXYETHYL STARCH IN SODIUM CHLORIDE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-1968-100026419681012 CONTAINER in 1 CASE (0264-1968-10) > 500 mL in 1 CONTAINER12 container2015-01-090000-00-00NoNoCurrent