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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202957-001HEPARIN SODIUMHEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12
A202957-002HEPARIN SODIUMHEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A202957-001AP
A202957-002AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12782e0a99824c…
2021-12-28 21:50 UTC2021-12A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202957-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202957-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202957-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202957-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202957-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202957-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202957-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202957-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202957-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202957-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202957-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202957-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202957-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202957-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202957-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202957-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202957-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202957-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202957-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202957-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202957-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202957-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202957-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202957-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202957-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202957-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202957-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202957-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202957-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202957-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202957-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202957-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202957-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202957-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202957-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202957-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202957-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202957-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202957-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202957-002AP1782e0a99824c…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ZZ45AB24CAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1361226Internal RxNorm lookup
1361574Internal RxNorm lookup
1361615Internal RxNorm lookup
1362831Internal RxNorm lookup
1658647Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c4c6bc1f-e0c7-fd0d-e053-2995a90abdefAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Heparin SodiumHEPARIN SODIUMMedical Purchasing Solutions, LLC4c118b39-cb4e-31a9-e063-6394a90a41b02026-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202957
application number: ANDA202957
Heparin SodiumHEPARIN SODIUMHepalink USA Inc.c4c6bc1f-e0c7-fd0d-e053-2995a90abdef2025-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202957
application number: ANDA202957
ndc (product): 81952-112
Heparin SodiumHEPARIN SODIUMNorthstar Rx LLC2edf6d35-5cf3-b7ff-e063-6394a90a4f332025-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202957
application number: ANDA202957
Heparin SodiumHEPARIN SODIUMSandoz Inc.1c634e53-44d6-cdcd-e063-6294a90a92e92025-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202957
application number: ANDA202957
Heparin SodiumHEPARIN SODIUMMcKesson Corporation dba SKY Packaging7f05762a-7527-4796-b21e-68277aec379e2025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202957
application number: ANDA202957

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