FDA.reportPublic FDA data

Heparin Sodium in Dextrose

Product NDC
0264-9587
11-digit product format
002649587
Labeler code
0264
Product ID
0264-9587_be724659-682a-48b4-bcc0-01be11d8b6e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium and Dextrose
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA019952
Marketing category
NDA
Marketing start
1992-07-20
Substance
DEXTROSE MONOHYDRATE; HEPARIN SODIUM
Active strength
5; 10000 g/100mL; [USP'U]/100mL
Pharmacologic classes
Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Heparin Sodium in Dextrose
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE5 g/100mL
HEPARIN SODIUM10000 [USP'U]/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX22YL083G, ZZ45AB24CA
Rxcui1361607, 1658717, 1659195

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac74f96-3910-44b9-8551-036880fbb1fbProduct name120260108
0a18eae4-4259-42db-86b6-915f66e83b06Product name120250729
2c999b01-2a13-4eff-8eb4-00b87316ef79Product name120231116
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
05193eb6-d122-ab0b-603b-d9dd92599836Product name220210204
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
2e5437ef-ff80-c9c2-2f66-5b7c771080beProduct name920180201
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
ae28a785-50d8-477d-a268-dffdfdd7504bProduct name120150305
0c878822-66ca-456d-c17d-0894b04fa473Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0264-9587-20Heparin Sodium in Dextrose24 in 1 CASEINJECTION2436
0264-9587-20Heparin Sodium in Dextrose250 mL in 1 CONTAINERINJECTION25036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-9587-20ML - Milliliter0264-95870e2e22ef-c9a9-48b7-a390-8e7bb2a0155e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROSE MONOHYDRATEACTIVE INGREDIENTLX22YL083GHEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE) INJECTION [B. BRAUN MEDICAL INC.]18
HEPARIN SODIUMACTIVE INGREDIENTZZ45AB24CAHEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE) INJECTION [B. BRAUN MEDICAL INC.]18
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OKHEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE) INJECTION [B. BRAUN MEDICAL INC.]18
HEPARINACTIVE MOIETYT2410KM04AHEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE) INJECTION [B. BRAUN MEDICAL INC.]18
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE) INJECTION [B. BRAUN MEDICAL INC.]18
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CHEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE) INJECTION [B. BRAUN MEDICAL INC.]18
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74HEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE) INJECTION [B. BRAUN MEDICAL INC.]18
WATERINACTIVE INGREDIENT059QF0KO0RHEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE) INJECTION [B. BRAUN MEDICAL INC.]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-9587HEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE) INJECTION [B. BRAUN MEDICAL INC.]36Current NDC, Legacy NDC, 2 package rows20240823_92a6f533-1a3d-4734-b413-d245592454e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1361607heparin sodium, porcine 20,000 UNT in 500 ML InjectionPSN92a6f533-1a3d-4734-b413-d245592454e336
1658717heparin sodium, porcine 25,000 UNT in 250 ML InjectionPSN92a6f533-1a3d-4734-b413-d245592454e336
1659195heparin sodium, porcine 25,000 UNT in 500 ML InjectionPSN92a6f533-1a3d-4734-b413-d245592454e336
1658717250 ML heparin sodium, porcine 100 UNT/ML InjectionSCD92a6f533-1a3d-4734-b413-d245592454e336
1361607500 ML heparin sodium, porcine 40 UNT/ML InjectionSCD92a6f533-1a3d-4734-b413-d245592454e336
1659195500 ML heparin sodium, porcine 50 UNT/ML InjectionSCD92a6f533-1a3d-4734-b413-d245592454e336
1361607heparin sodium, porcine 20,000 UNT per 500 ML InjectionSY92a6f533-1a3d-4734-b413-d245592454e336
1658717heparin sodium, porcine 25,000 UNT per 250 ML InjectionSY92a6f533-1a3d-4734-b413-d245592454e336
1659195heparin sodium, porcine 25,000 UNT per 500 ML InjectionSY92a6f533-1a3d-4734-b413-d245592454e336

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-9587-200026495872024 CONTAINER in 1 CASE (0264-9587-20) / 250 mL in 1 CONTAINER24 container1992-07-200000-00-00NoNoCurrent