FDA.reportPublic FDA data

Heparin Sodium

Product NDC
63323-542
11-digit product format
633230542
Labeler code
63323
Product ID
63323-542_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
10000 [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 SODIUM10000 [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
05193eb6-d122-ab0b-603b-d9dd92599836Product name220210204
2e5437ef-ff80-c9c2-2f66-5b7c771080beProduct name920180201
ae28a785-50d8-477d-a268-dffdfdd7504bProduct name120150305
0c878822-66ca-456d-c17d-0894b04fa473Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-542-01Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION2513
63323-542-01Heparin Sodium1 mL in 1 VIALINJECTION, SOLUTION113
63323-542-07Heparin Sodium5 mL in 1 VIALINJECTION, SOLUTION513
63323-542-07Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION2513
63323-542-04Heparin Sodium5 mL in 1 VIALINJECTION, SOLUTION56
63323-542-09Heparin Sodium1 mL in 1 VIALINJECTION, SOLUTION16
63323-542-13Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION256
63323-542-14Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-542-01ML - Milliliter63323-542ba9d5dda-341b-44d0-910f-8d5d36aa754c12012-07-24
63323-542-07ML - Milliliter63323-542d9a06bcb-0b04-4181-80e2-015321c99db512012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-542HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]12Current NDC, Legacy NDC, 4 package rows20241017_d55b4a63-0c04-4874-b74f-9e9b9e8b008c.zip
63323-542HEPARIN SODIUM (HEPARIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]4Current NDC, Legacy NDC, 4 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
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
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionPSN971505d4-f78c-6f5d-e053-2995a90a00e05
1362831heparin sodium, porcine 10000 UNT/ML Injectable SolutionSCD971505d4-f78c-6f5d-e053-2995a90a00e05
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionSY971505d4-f78c-6f5d-e053-2995a90a00e05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-542-016332305420125 VIAL in 1 TRAY (63323-542-01) > 1 mL in 1 VIAL25 vial2000-07-110000-00-00NoNoCurrent
63323-542-04633230542045 mL in 1 VIAL5 mlHistorical
63323-542-076332305420725 VIAL in 1 TRAY (63323-542-07) > 5 mL in 1 VIAL25 vial2000-07-110000-00-00NoNoCurrent
63323-542-09633230542091 mL in 1 VIAL1 mlHistorical
63323-542-136332305421325 VIAL in 1 TRAY (63323-542-13) / 1 mL in 1 VIAL (63323-542-09) 25 vial2019-11-040000-00-00NoNoCurrent
63323-542-146332305421425 VIAL in 1 TRAY (63323-542-14) / 5 mL in 1 VIAL (63323-542-04) 25 vial2019-11-040000-00-00NoNoCurrent