FDA.reportPublic FDA data

Heparin Sodium

Product NDC
63323-523
11-digit product format
633230523
Labeler code
63323
Product ID
63323-523_c656be9f-793a-4d25-b563-539dce89cbc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HEPARIN SODIUM
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA017029
Marketing category
NDA
Marketing start
2017-08-24
Substance
HEPARIN SODIUM
Active strength
10000 [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
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA
Rxcui1658717, 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
63323-523-01Heparin Sodium250 mL in 1 BAGINJECTION, SOLUTION2508
63323-523-74Heparin Sodium24 in 1 CASEINJECTION, SOLUTION248

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-523-74ML - Milliliter63323-523068638bc-c543-42d2-9877-736d3d47b21312018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-523HEPARIN SODIUM (HEPARIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]8Current NDC, Legacy NDC, 2 package rows20240503_cb1c1e7a-c9ca-4a07-8833-e45ce436d287.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658717heparin sodium, porcine 25,000 UNT in 250 ML InjectionPSNcb1c1e7a-c9ca-4a07-8833-e45ce436d2878
1659195heparin sodium, porcine 25,000 UNT in 500 ML InjectionPSNcb1c1e7a-c9ca-4a07-8833-e45ce436d2878
1658717250 ML heparin sodium, porcine 100 UNT/ML InjectionSCDcb1c1e7a-c9ca-4a07-8833-e45ce436d2878
1659195500 ML heparin sodium, porcine 50 UNT/ML InjectionSCDcb1c1e7a-c9ca-4a07-8833-e45ce436d2878
1658717heparin sodium, porcine 25,000 UNT per 250 ML InjectionSYcb1c1e7a-c9ca-4a07-8833-e45ce436d2878
1659195heparin sodium, porcine 25,000 UNT per 500 ML InjectionSYcb1c1e7a-c9ca-4a07-8833-e45ce436d2878

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-523-0163323052301250 mL in 1 BAG250 mlHistorical
63323-523-746332305237424 BAG in 1 CASE (63323-523-74) / 250 mL in 1 BAG (63323-523-01) 24 bag2017-08-240000-00-00NoNoCurrent