FDA.reportPublic FDA data

Heparin Sodium

Product NDC
63323-540
11-digit product format
633230540
Labeler code
63323
Product ID
63323-540_529104c9-6154-4428-953d-5546875f32e5
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
1972-02-22
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, 1361574, 1361615, 1362831, 1658634, 1658647

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
05193eb6-d122-ab0b-603b-d9dd92599836Product name220210204
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
2e5437ef-ff80-c9c2-2f66-5b7c771080beProduct name920180201
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
ae28a785-50d8-477d-a268-dffdfdd7504bProduct name120150305
0c878822-66ca-456d-c17d-0894b04fa473Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-540-01Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION2513
63323-540-01Heparin Sodium1 mL in 1 VIALINJECTION, SOLUTION113
63323-540-11Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION2513
63323-540-11Heparin Sodium10 mL in 1 VIALINJECTION, SOLUTION1013
63323-540-31Heparin Sodium30 mL in 1 VIALINJECTION, SOLUTION3013
63323-540-31Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION2513
63323-540-07Heparin Sodium10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION108
63323-540-57Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION258
63323-540-57Heparin Sodium10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION108
63323-540-67Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION258
63323-540-03Heparin Sodium1 mL in 1 VIALINJECTION, SOLUTION16
63323-540-05Heparin Sodium10 mL in 1 VIALINJECTION, SOLUTION106
63323-540-13Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION256
63323-540-15Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION256
63323-540-33Heparin Sodium30 mL in 1 VIALINJECTION, SOLUTION306
63323-540-36Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-540-01ML - Milliliter63323-540024fa552-6204-4e77-9f6e-4c0684f51dbb12012-07-24
63323-540-05ML - Milliliter63323-540ee4e1b04-6190-4ea0-ab56-4f8ffc7dbbaf12020-03-10
63323-540-07ML - Milliliter63323-540f293c8c8-01d1-4d7c-995c-dd999fb6121a12020-05-08
63323-540-11ML - Milliliter63323-540d5968e33-0e69-4f64-b3b5-53f3cfe7636212012-07-24
63323-540-15ML - Milliliter63323-54021eb9286-76c6-4ece-b3e3-48758576b3da12020-03-10
63323-540-31ML - Milliliter63323-54096e8f5c0-dd25-47fd-8605-2ebae9ca7dda12012-07-24
63323-540-33ML - Milliliter63323-540d9e2a1ea-d2a9-4a0d-961c-ebb9b5bf4d1a12020-03-10
63323-540-36ML - Milliliter63323-5403bc1d874-e02b-455f-852c-ca7b99c07b8a12020-03-10
63323-540-57ML - Milliliter63323-540d928465d-a023-4c61-92a6-7567726a785812012-07-24
63323-540-67ML - Milliliter63323-540e86a3f10-7c2b-44e5-99aa-b7f63776425f12020-05-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HEPARIN SODIUMACTIVE INGREDIENTZZ45AB24CAHEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9
HEPARINACTIVE MOIETYT2410KM04AHEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHHEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBHEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XHEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9
HEPARIN SODIUMACTIVE INGREDIENTZZ45AB24CAHEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
HEPARINACTIVE MOIETYT2410KM04AHEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBHEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XHEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4
Heparin SodiumACTIVE INGREDIENTZZ45AB24CAHEPARIN SODIUM INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]1
HeparinACTIVE MOIETYT2410KM04AHEPARIN SODIUM INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-540HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]12Current NDC, Legacy NDC, 6 package rows20241017_d55b4a63-0c04-4874-b74f-9e9b9e8b008c.zip
63323-540HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 4 package rows20211003_ed937dd2-8fab-4875-a1e8-627b71ccb7fb.zip
63323-540HEPARIN SODIUM (HEPARIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]4Current NDC, Legacy NDC, 6 package rows20220129_2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionPSNd55b4a63-0c04-4874-b74f-9e9b9e8b008c13
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionPSNd55b4a63-0c04-4874-b74f-9e9b9e8b008c13
1361574heparin sodium, porcine 20,000 UNT/ML Injectable SolutionPSNd55b4a63-0c04-4874-b74f-9e9b9e8b008c13
1658647heparin sodium, porcine 2000 UNT in 2 ML InjectionPSNd55b4a63-0c04-4874-b74f-9e9b9e8b008c13
1658634heparin sodium, porcine 5000 UNT in 0.5 mL InjectionPSNd55b4a63-0c04-4874-b74f-9e9b9e8b008c13
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionPSNd55b4a63-0c04-4874-b74f-9e9b9e8b008c13
16586340.5 ML heparin sodium, porcine 10000 UNT/ML InjectionSCDd55b4a63-0c04-4874-b74f-9e9b9e8b008c13
16586472 ML heparin sodium, porcine 1000 UNT/ML InjectionSCDd55b4a63-0c04-4874-b74f-9e9b9e8b008c13
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionSCDd55b4a63-0c04-4874-b74f-9e9b9e8b008c13
1362831heparin sodium, porcine 10000 UNT/ML Injectable SolutionSCDd55b4a63-0c04-4874-b74f-9e9b9e8b008c13
1361574heparin sodium, porcine 20000 UNT/ML Injectable SolutionSCDd55b4a63-0c04-4874-b74f-9e9b9e8b008c13
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionSCDd55b4a63-0c04-4874-b74f-9e9b9e8b008c13
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionSYd55b4a63-0c04-4874-b74f-9e9b9e8b008c13
1361574heparin sodium, porcine 20,000 UNT/ML Injectable SolutionSYd55b4a63-0c04-4874-b74f-9e9b9e8b008c13
1658647heparin sodium, porcine 2000 UNT per 2 ML InjectionSYd55b4a63-0c04-4874-b74f-9e9b9e8b008c13
1658634heparin sodium, porcine 5000 UNT per 0.5 ML InjectionSYd55b4a63-0c04-4874-b74f-9e9b9e8b008c13
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionPSNed937dd2-8fab-4875-a1e8-627b71ccb7fb8
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionPSNed937dd2-8fab-4875-a1e8-627b71ccb7fb8
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionSCDed937dd2-8fab-4875-a1e8-627b71ccb7fb8
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionSCDed937dd2-8fab-4875-a1e8-627b71ccb7fb8
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionPSN2a173253-dfdc-4d9d-8dee-b9c13e6fa9f56
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionPSN2a173253-dfdc-4d9d-8dee-b9c13e6fa9f56
1361574heparin sodium, porcine 20,000 UNT/ML Injectable SolutionPSN2a173253-dfdc-4d9d-8dee-b9c13e6fa9f56
1658634heparin sodium, porcine 5000 UNT in 0.5 mL InjectionPSN2a173253-dfdc-4d9d-8dee-b9c13e6fa9f56
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionPSN2a173253-dfdc-4d9d-8dee-b9c13e6fa9f56
16586340.5 ML heparin sodium, porcine 10000 UNT/ML InjectionSCD2a173253-dfdc-4d9d-8dee-b9c13e6fa9f56
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionSCD2a173253-dfdc-4d9d-8dee-b9c13e6fa9f56
1362831heparin sodium, porcine 10000 UNT/ML Injectable SolutionSCD2a173253-dfdc-4d9d-8dee-b9c13e6fa9f56
1361574heparin sodium, porcine 20000 UNT/ML Injectable SolutionSCD2a173253-dfdc-4d9d-8dee-b9c13e6fa9f56
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionSCD2a173253-dfdc-4d9d-8dee-b9c13e6fa9f56
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionSY2a173253-dfdc-4d9d-8dee-b9c13e6fa9f56
1361574heparin sodium, porcine 20,000 UNT/ML Injectable SolutionSY2a173253-dfdc-4d9d-8dee-b9c13e6fa9f56
1658634heparin sodium, porcine 5000 UNT per 0.5 ML InjectionSY2a173253-dfdc-4d9d-8dee-b9c13e6fa9f56
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionPSN3a998729-c912-4e21-8e49-d1e72ba6fe9e5
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionSCD3a998729-c912-4e21-8e49-d1e72ba6fe9e5
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionPSN239b4816-6a55-451b-bf40-e611be07d12f4
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionSCD239b4816-6a55-451b-bf40-e611be07d12f4
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionPSN631dc216-df9e-4126-b59e-c8079ba6e2872
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionSCD631dc216-df9e-4126-b59e-c8079ba6e2872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-540-016332305400125 VIAL in 1 TRAY (63323-540-01) > 1 mL in 1 VIAL25 vial1999-09-270000-00-00NoNoCurrent
63323-540-03633230540031 mL in 1 VIAL1 mlHistorical
63323-540-056332305400510 mL in 1 VIAL10 mlHistorical
63323-540-076332305400710 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
63323-540-116332305401125 VIAL in 1 TRAY (63323-540-11) > 10 mL in 1 VIAL25 vial1999-09-270000-00-00NoNoCurrent
63323-540-136332305401325 VIAL in 1 TRAY (63323-540-13) / 1 mL in 1 VIAL (63323-540-03) 25 vial2019-11-040000-00-00NoNoCurrent
63323-540-156332305401525 VIAL in 1 TRAY (63323-540-15) / 10 mL in 1 VIAL (63323-540-05) 25 vial2019-11-040000-00-00NoNoCurrent
63323-540-316332305403125 VIAL in 1 TRAY (63323-540-31) > 30 mL in 1 VIAL25 vial1999-09-270000-00-00NoNoCurrent
63323-540-336332305403330 mL in 1 VIAL30 mlHistorical
63323-540-366332305403625 VIAL in 1 TRAY (63323-540-36) / 30 mL in 1 VIAL (63323-540-33) 25 vial2019-11-040000-00-00NoNoCurrent
63323-540-576332305405725 VIAL, MULTI-DOSE in 1 TRAY (63323-540-57) > 10 mL in 1 VIAL, MULTI-DOSE1999-09-270000-00-00NoNoCurrent
63323-540-676332305406725 VIAL, MULTI-DOSE in 1 TRAY (63323-540-67) / 10 mL in 1 VIAL, MULTI-DOSE (63323-540-07) 2020-03-250000-00-00NoNoCurrent