FDA.reportPublic FDA data

Heparin Sodium

Product NDC
81565-203
11-digit product format
815650203
Labeler code
81565
Product ID
81565-203_4bebb181-0ed2-44b0-af0d-4802862e73b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HEPARIN SODIUM
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Phlow Corporation
Application
NDA017029
Marketing category
NDA
Marketing start
2022-03-07
Substance
HEPARIN SODIUM
Active strength
1000 [USP'U]/mL
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 SODIUM1000 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA
Rxcui1361226

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
81565-203-022024-02-22C16284748780-11030e365-63e5-111a-e063-dadaa90a10e2These 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
81565-203-022024-01-30C16284748780-11030e365-63e5-111a-e063-dadaa90a10e2These 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
81565-203-01Heparin Sodium10 mL in 1 VIALINJECTION, SOLUTION103
81565-203-02Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81565-203-01ML - Milliliter81565-203150fb848-df29-43c3-ba4f-d1115caf742112025-10-14
81565-203-02ML - Milliliter81565-2034cf12303-a7d5-4b69-8e2e-28c8a4e04c6012022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81565-203HEPARIN SODIUM (HEPARIN SODIUM) INJECTION, SOLUTION [PHLOW CORPORATION]3Current NDC, Legacy NDC, 2 package rows20240522_cece935c-1c0a-4949-b023-d6df3d53fbfa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionPSNcece935c-1c0a-4949-b023-d6df3d53fbfa3
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionSCDcece935c-1c0a-4949-b023-d6df3d53fbfa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81565-203-018156502030110 mL in 1 VIAL10 mlHistorical
81565-203-028156502030225 VIAL in 1 TRAY (81565-203-02) / 10 mL in 1 VIAL (81565-203-01) 25 vial2022-03-070000-00-00NoNoCurrent