FDA.reportPublic FDA data

Heparin Sodium

Product NDC
0409-2723
11-digit product format
004092723
Labeler code
0409
Product ID
0409-2723_46822bf7-c4f1-4cd5-9662-bdd465514ce8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HEPARIN SODIUM
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Hospira, Inc.
Application
ANDA090571
Marketing category
ANDA
Marketing start
2009-08-31
Substance
HEPARIN SODIUM
Active strength
5000 [USP'U]/mL
Pharmacologic classes
Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Heparin Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPARIN SODIUM5000 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA
Rxcui1361226, 1361615, 1658637, 1658659, 1659263

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
0409-2723-012023-08-01C16284748780-10191ceaa-67e6-198a-e063-dbdaa90aec3eThese 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, USP for intravenous or subcutaneous use Initial U.S. Approval: 1939
0409-2723-022023-08-01C16284748780-10191ceaa-67e6-198a-e063-dbdaa90aec3eThese 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, USP for intravenous or subcutaneous use Initial U.S. Approval: 1939
0409-2723-012023-07-28C16284748780-10191ceaa-67e6-198a-e063-dbdaa90aec3eThese 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, USP for intravenous or subcutaneous use Initial U.S. Approval: 1939
0409-2723-022023-07-28C16284748780-10191ceaa-67e6-198a-e063-dbdaa90aec3eThese 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, USP for intravenous or subcutaneous use Initial U.S. Approval: 1939

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-2723-01Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION2525
0409-2723-02Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION2525
0409-2723-30Heparin Sodium1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION125
0409-2723-31Heparin Sodium10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2723-01ML - Milliliter0409-2723c1e9e509-be50-4c1c-83b9-b267c13658a512012-07-24
0409-2723-02ML - Milliliter0409-27233199adf1-a9d0-496d-81a4-3a2f6dd4f6e512012-07-24
0409-2723-30ML - Milliliter0409-27230935833a-c750-4639-9cd5-20bdbf0d20a412017-07-07
0409-2723-31ML - Milliliter0409-2723efe59a45-5e62-43d7-b8f7-f39d7fe275b412017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HEPARIN SODIUMACTIVE INGREDIENTZZ45AB24CAHEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]14
HEPARINACTIVE MOIETYT2410KM04AHEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]14
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHHEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]14
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBHEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]14
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XHEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]14
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]14
WATERINACTIVE INGREDIENT059QF0KO0RHEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]14
HEPARIN SODIUMACTIVE INGREDIENTZZ45AB24CAHEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH]3
HEPARINACTIVE MOIETYT2410KM04AHEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHHEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBHEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XHEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH]3
WATERINACTIVE INGREDIENT059QF0KO0RHEPARIN SODIUM INJECTION, SOLUTION [CARDINAL HEALTH]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-2723HEPARIN SODIUM INJECTION, SOLUTION [HOSPIRA, INC.]23Current NDC, Legacy NDC, 4 package rows20241126_6c181d7e-aed2-4975-30ac-d39a94cca7ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658637heparin sodium, porcine 10,000 UNT in 1 ML InjectionPSN6c181d7e-aed2-4975-30ac-d39a94cca7ec25
1658659heparin sodium, porcine 1000 UNT in 1 ML InjectionPSN6c181d7e-aed2-4975-30ac-d39a94cca7ec25
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionPSN6c181d7e-aed2-4975-30ac-d39a94cca7ec25
1659263heparin sodium, porcine 5000 UNT in 1 ML InjectionPSN6c181d7e-aed2-4975-30ac-d39a94cca7ec25
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionPSN6c181d7e-aed2-4975-30ac-d39a94cca7ec25
16586591 ML heparin sodium, porcine 1000 UNT/ML InjectionSCD6c181d7e-aed2-4975-30ac-d39a94cca7ec25
16586371 ML heparin sodium, porcine 10000 UNT/ML InjectionSCD6c181d7e-aed2-4975-30ac-d39a94cca7ec25
16592631 ML heparin sodium, porcine 5000 UNT/ML InjectionSCD6c181d7e-aed2-4975-30ac-d39a94cca7ec25
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionSCD6c181d7e-aed2-4975-30ac-d39a94cca7ec25
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionSCD6c181d7e-aed2-4975-30ac-d39a94cca7ec25
1658637heparin sodium, porcine 10,000 UNT per 1 ML InjectionSY6c181d7e-aed2-4975-30ac-d39a94cca7ec25
1658659heparin sodium, porcine 1000 UNT per 1 ML InjectionSY6c181d7e-aed2-4975-30ac-d39a94cca7ec25
1659263heparin sodium, porcine 5000 UNT per 1 ML InjectionSY6c181d7e-aed2-4975-30ac-d39a94cca7ec25
1659263heparin sodium, porcine 5000 UNT in 1 ML InjectionPSN9cd7abe6-3923-4007-8491-273ef6e05ad718
16592631 ML heparin sodium, porcine 5000 UNT/ML InjectionSCD9cd7abe6-3923-4007-8491-273ef6e05ad718
1659263heparin sodium, porcine 5000 UNT per 1 ML InjectionSY9cd7abe6-3923-4007-8491-273ef6e05ad718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-2723-010040927230125 VIAL, SINGLE-DOSE in 1 TRAY (0409-2723-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-2723-30) 2009-08-310000-00-00NoNoCurrent
0409-2723-020040927230225 VIAL, MULTI-DOSE in 1 TRAY (0409-2723-02) / 10 mL in 1 VIAL, MULTI-DOSE (0409-2723-31) 2009-08-310000-00-00NoNoCurrent
0409-2723-30004092723301 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
0409-2723-310040927233110 mL in 1 VIAL, MULTI-DOSE10 mlHistorical