Heparin Sodium

Product NDC
63323-262
11-digit product format
633230262
Labeler code
63323
Product ID
63323-262_348567ec-3cce-4ba2-b1ef-49f50eac863a
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
2020-03-02
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
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]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZZ45AB24CA
Rxcui1361615

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
63323-262-01Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION2513
63323-262-01Heparin Sodium1 mL in 1 VIALINJECTION, SOLUTION113
63323-262-09Heparin Sodium1 mL in 1 VIALINJECTION, SOLUTION18
63323-262-26Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION258
63323-262-55Heparin Sodium1 mL in 1 VIALINJECTION, SOLUTION18
63323-262-55Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION258
63323-262-03Heparin Sodium1 mL in 1 VIALINJECTION, SOLUTION16
63323-262-06Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION256
63323-262-11Heparin Sodium1 mL in 1 VIALINJECTION, SOLUTION12
63323-262-36Heparin Sodium25 in 1 TRAYINJECTION, SOLUTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-262-01ML - Milliliter63323-2627b9d701f-5fd7-4353-8df3-d197e4fc1ee412012-07-24
63323-262-03ML - Milliliter63323-262f47af711-f4c6-4071-ad70-82e25c4ffa0f12020-03-10
63323-262-06ML - Milliliter63323-2624f065a22-1ca0-4ca9-ad15-d6812f73385f12020-03-10
63323-262-09ML - Milliliter63323-2627e5a48ff-ca18-41e3-98f5-3d00ee5be01812020-06-05
63323-262-11ML - Milliliter63323-262594d7a8c-4520-4dbd-ad09-ca7cde37169412020-05-08
63323-262-26ML - Milliliter63323-26290c4b495-6153-4a3d-a233-82c90d5158d512020-06-05
63323-262-36ML - Milliliter63323-2628275de90-fdea-429b-a542-823990affb0e12020-05-08
63323-262-55ML - Milliliter63323-262e67b6b86-9520-4892-92f5-53acf3e7ec4612012-07-24

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
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
63323-262HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]12Current NDC, Legacy NDC, 2 package rows20241017_d55b4a63-0c04-4874-b74f-9e9b9e8b008c.zip
63323-262HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 4 package rows20211003_ed937dd2-8fab-4875-a1e8-627b71ccb7fb.zip
63323-262HEPARIN SODIUM (HEPARIN SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]4Current NDC, Legacy NDC, 2 package rows20220129_2a173253-dfdc-4d9d-8dee-b9c13e6fa9f5.zip
63323-262HEPARIN SODIUM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2Current NDC, Legacy NDC, 2 package rows20211003_3facd525-b9ad-46d0-b63e-f13a5f6d591d.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
1658634heparin sodium, porcine 5000 UNT in 0.5 mL InjectionPSNf67eea4e-80ff-48da-8b04-8addc5cd31d15
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionPSNf67eea4e-80ff-48da-8b04-8addc5cd31d15
16586340.5 ML heparin sodium, porcine 10000 UNT/ML InjectionSCDf67eea4e-80ff-48da-8b04-8addc5cd31d15
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionSCDf67eea4e-80ff-48da-8b04-8addc5cd31d15
1658634heparin sodium, porcine 5000 UNT per 0.5 ML InjectionSYf67eea4e-80ff-48da-8b04-8addc5cd31d15
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionPSN3facd525-b9ad-46d0-b63e-f13a5f6d591d2
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionPSN6467d400-d373-4137-af06-568b98813c8e2
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionSCD3facd525-b9ad-46d0-b63e-f13a5f6d591d2
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionSCD6467d400-d373-4137-af06-568b98813c8e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-262-016332302620125 VIAL in 1 TRAY (63323-262-01) > 1 mL in 1 VIAL25 vial2000-03-190000-00-00NoNoCurrent
63323-262-03633230262031 mL in 1 VIAL1 mlHistorical
63323-262-066332302620625 VIAL in 1 TRAY (63323-262-06) / 1 mL in 1 VIAL (63323-262-03) 25 vial2020-03-250000-00-00NoNoCurrent
63323-262-09633230262091 mL in 1 VIAL1 mlHistorical
63323-262-11633230262111 mL in 1 VIAL1 mlHistorical
63323-262-266332302622625 VIAL in 1 TRAY (63323-262-26) / 1 mL in 1 VIAL (63323-262-09) 25 vial2020-03-250000-00-00NoNoCurrent
63323-262-366332302623625 VIAL in 1 TRAY (63323-262-36) / 1 mL in 1 VIAL (63323-262-11) 25 vial2020-03-020000-00-00NoNoCurrent
63323-262-556332302625525 VIAL in 1 TRAY (63323-262-55) > 1 mL in 1 VIAL25 vial2000-03-190000-00-00NoNoCurrent