FDA.reportPublic FDA data

Heparin Sodium

Product NDC
81952-112
11-digit product format
819520112
Labeler code
81952
Product ID
81952-112_2e8e07a4-763e-79e5-e063-6394a90a7619
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Hepalink USA Inc.
Application
ANDA202957
Marketing category
ANDA
Marketing start
2014-06-12
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, 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81952-112-01Heparin Sodium1 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION114
81952-112-04Heparin Sodium10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1014
81952-112-05Heparin Sodium30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION3014
81952-112-06Heparin Sodium25 in 1 CARTONINJECTION, SOLUTION2514
81952-112-09Heparin Sodium25 in 1 CARTONINJECTION, SOLUTION2514
81952-112-10Heparin Sodium25 in 1 CARTONINJECTION, SOLUTION2514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81952-112-01ML - Milliliter81952-112956910d4-e722-4572-a821-eceeeb2a1b1c12022-08-04
81952-112-04ML - Milliliter81952-112599e073f-ec27-4dca-a0b4-a3ba3d7c66ea12022-08-04
81952-112-05ML - Milliliter81952-112bdb32978-6dd3-490a-889f-397e2e85c23212022-11-07
81952-112-06ML - Milliliter81952-112381f596b-2c9d-4dba-a0b2-baae3f8751e912022-08-04
81952-112-09ML - Milliliter81952-112456e10d0-217e-403d-bcac-29b0296c6fc412022-08-04
81952-112-10ML - Milliliter81952-1121d639276-70ec-40be-9a5d-9df1fbf447d312022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81952-112HEPARIN SODIUM INJECTION, SOLUTION [HEPALINK USA INC.]14Current NDC, Legacy NDC, 6 package rows20250223_c4c6bc1f-e0c7-fd0d-e053-2995a90abdef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionPSNc4c6bc1f-e0c7-fd0d-e053-2995a90abdef14
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionPSNc4c6bc1f-e0c7-fd0d-e053-2995a90abdef14
1361574heparin sodium, porcine 20,000 UNT/ML Injectable SolutionPSNc4c6bc1f-e0c7-fd0d-e053-2995a90abdef14
1658647heparin sodium, porcine 2000 UNT in 2 ML InjectionPSNc4c6bc1f-e0c7-fd0d-e053-2995a90abdef14
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionPSNc4c6bc1f-e0c7-fd0d-e053-2995a90abdef14
16586472 ML heparin sodium, porcine 1000 UNT/ML InjectionSCDc4c6bc1f-e0c7-fd0d-e053-2995a90abdef14
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionSCDc4c6bc1f-e0c7-fd0d-e053-2995a90abdef14
1362831heparin sodium, porcine 10000 UNT/ML Injectable SolutionSCDc4c6bc1f-e0c7-fd0d-e053-2995a90abdef14
1361574heparin sodium, porcine 20000 UNT/ML Injectable SolutionSCDc4c6bc1f-e0c7-fd0d-e053-2995a90abdef14
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionSCDc4c6bc1f-e0c7-fd0d-e053-2995a90abdef14
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionSYc4c6bc1f-e0c7-fd0d-e053-2995a90abdef14
1361574heparin sodium, porcine 20,000 UNT/ML Injectable SolutionSYc4c6bc1f-e0c7-fd0d-e053-2995a90abdef14
1658647heparin sodium, porcine 2000 UNT per 2 ML InjectionSYc4c6bc1f-e0c7-fd0d-e053-2995a90abdef14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81952-112-01819520112011 mL in 1 VIAL, MULTI-DOSE1 mlHistorical
81952-112-048195201120410 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
81952-112-058195201120530 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
81952-112-068195201120625 VIAL, MULTI-DOSE in 1 CARTON (81952-112-06) / 1 mL in 1 VIAL, MULTI-DOSE (81952-112-01) 2014-06-120000-00-00NoNoCurrent
81952-112-098195201120925 VIAL, MULTI-DOSE in 1 CARTON (81952-112-09) / 10 mL in 1 VIAL, MULTI-DOSE (81952-112-04) 2014-06-120000-00-00NoNoCurrent
81952-112-108195201121025 VIAL, MULTI-DOSE in 1 CARTON (81952-112-10) / 30 mL in 1 VIAL, MULTI-DOSE (81952-112-05) 2014-06-120000-00-00NoNoCurrent