FDA.reportPublic FDA data

Heparin Sodium

Product NDC
63323-118
11-digit product format
633230118
Labeler code
63323
Product ID
63323-118_47596159-4f76-4ac2-984e-4d3426a04a35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA017029
Marketing category
NDA
Marketing start
2018-11-16
Substance
HEPARIN SODIUM
Active strength
5000 [USP'U]/.5mL
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 SODIUM5000 [USP'U]/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA
Rxcui2121591

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63323-118-052021-08-19C16284748780-1c7ccaba7-27f0-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use HEPARIN SODIUM INJECTION safely and effectively. See full prescribing information for HEPARIN SODIUM INJECTION. HEPARIN SODIUM INJECTION, for intravenous or subcutaneous use Initial U.S. Approval: 1939
63323-118-052021-07-23C16284748780-1c7ccaba7-27f0-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use HEPARIN SODIUM INJECTION safely and effectively. See full prescribing information for HEPARIN SODIUM INJECTION. HEPARIN SODIUM INJECTION, for intravenous or subcutaneous use Initial U.S. Approval: 1939

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-118-01Heparin Sodium0.5 mL in 1 SYRINGEINJECTION, SOLUTION0.53
63323-118-01Heparin Sodium1 in 1 BLISTER PACKINJECTION, SOLUTION13
63323-118-05Heparin Sodium24 in 1 CARTONINJECTION, SOLUTION243

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-118-01ML - Milliliter63323-118db121745-3186-450d-86cc-47691b67b2c512019-08-06
63323-118-05ML - Milliliter63323-118a4509609-b883-4761-a91c-f3be45536ed512019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-118HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2Current NDC, Legacy NDC, 3 package rows20210820_9207cef5-4cec-41e7-a351-29ba726feb44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2121591heparin sodium, porcine 5000 UNT in 0.5 mL Prefilled SyringePSN9207cef5-4cec-41e7-a351-29ba726feb443
21215910.5 ML heparin sodium, porcine 10000 UNT/ML Prefilled SyringeSCD9207cef5-4cec-41e7-a351-29ba726feb443
2121591heparin sodium, porcine 5000 UNT per 0.5 ML Prefilled SyringeSY9207cef5-4cec-41e7-a351-29ba726feb443

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-118-01633230118010.5 mL in 1 SYRINGE0.5 mlHistorical
63323-118-056332301180524 BLISTER PACK in 1 CARTON (63323-118-05) / 1 SYRINGE in 1 BLISTER PACK (63323-118-01) / .5 mL in 1 SYRINGE24 blister pack2018-11-160000-00-00NoNoCurrent