FDA.reportPublic FDA data

Heparin Sodium in Sodium Chloride

Product NDC
0264-9872
11-digit product format
002649872
Labeler code
0264
Product ID
0264-9872_48e17807-e73d-4ea2-81bc-901355903aa7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium in Sodium Chloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA019953
Marketing category
NDA
Marketing start
1992-07-20
Substance
HEPARIN SODIUM
Active strength
200 [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 Sodium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPARIN SODIUM200 [USP'U]/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA
Rxcui1658690, 1658692

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
05193eb6-d122-ab0b-603b-d9dd92599836Product name220210204
2e5437ef-ff80-c9c2-2f66-5b7c771080beProduct name920180201
ae28a785-50d8-477d-a268-dffdfdd7504bProduct name120150305
0c878822-66ca-456d-c17d-0894b04fa473Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0264-9872-00Heparin Sodium in Sodium Chloride1000 mL in 1 CONTAINERINJECTION100028
0264-9872-00Heparin Sodium in Sodium Chloride12 in 1 CASEINJECTION1228
0264-9872-10Heparin Sodium in Sodium Chloride24 in 1 CASEINJECTION2428
0264-9872-10Heparin Sodium in Sodium Chloride500 mL in 1 CONTAINERINJECTION50028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-9872-00ML - Milliliter0264-9872ff7add4f-09e4-4e9d-a55c-6ad8416da6f312024-02-14
0264-9872-10ML - Milliliter0264-9872a4b0d956-d2b0-4af2-93fd-aa40ed1cb2ce12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HEPARIN SODIUMACTIVE INGREDIENTZZ45AB24CAHEPARIN SODIUM IN SODIUM CHLORIDE INJECTION [B. BRAUN MEDICAL INC.]11
HEPARINACTIVE MOIETYT2410KM04AHEPARIN SODIUM IN SODIUM CHLORIDE INJECTION [B. BRAUN MEDICAL INC.]11
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLHEPARIN SODIUM IN SODIUM CHLORIDE INJECTION [B. BRAUN MEDICAL INC.]11
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XHEPARIN SODIUM IN SODIUM CHLORIDE INJECTION [B. BRAUN MEDICAL INC.]11
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION [B. BRAUN MEDICAL INC.]11
WATERINACTIVE INGREDIENT059QF0KO0RHEPARIN SODIUM IN SODIUM CHLORIDE INJECTION [B. BRAUN MEDICAL INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-9872HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION [B. BRAUN MEDICAL INC.]26Current NDC, Legacy NDC, 4 package rows20231219_a3041c04-0ea8-4d36-81ce-c5091c906316.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658692heparin sodium, porcine 1000 UNT in 500 ML InjectionPSNa3041c04-0ea8-4d36-81ce-c5091c90631628
1658690heparin sodium, porcine 2000 UNT in 1000 ML InjectionPSNa3041c04-0ea8-4d36-81ce-c5091c90631628
16586901000 ML heparin sodium, porcine 2 UNT/ML InjectionSCDa3041c04-0ea8-4d36-81ce-c5091c90631628
1658692500 ML heparin sodium, porcine 2 UNT/ML InjectionSCDa3041c04-0ea8-4d36-81ce-c5091c90631628
1658692heparin sodium, porcine 1000 UNT per 500 ML InjectionSYa3041c04-0ea8-4d36-81ce-c5091c90631628
1658690heparin sodium, porcine 2000 UNT per 1000 ML InjectionSYa3041c04-0ea8-4d36-81ce-c5091c90631628

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-9872-000026498720012 CONTAINER in 1 CASE (0264-9872-00) / 1000 mL in 1 CONTAINER12 container2023-12-15NoNoCurrent
0264-9872-100026498721024 CONTAINER in 1 CASE (0264-9872-10) / 500 mL in 1 CONTAINER24 container1992-07-200000-00-00NoNoCurrent