Heparin Sodium

Product NDC
0781-3540
11-digit product format
007813540
Labeler code
0781
Product ID
0781-3540_2ef18b0f-ccc2-5539-e063-6394a90a2a4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Sandoz 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 42.

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202957-001HEPARIN SODIUM1,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12caaa826d4ba7…
2026-08-18 06:07:402026-07A202957-002HEPARIN SODIUM5,000 UNITS/MLINJECTABLE / INJECTIONAP2014-06-12caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202957-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A202957-002AP1caaa826d4ba7…
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…

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
1c634e53-44d6-cdcd-e063-6294a90a92e9Available 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
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
0781-3540-10Heparin Sodium10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION104
0781-3540-25Heparin Sodium25 in 1 CARTONINJECTION, SOLUTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3540-10ML - Milliliter0781-3540e88592fe-ea4d-4940-b402-e6f60ffb449512024-10-04
0781-3540-25ML - Milliliter0781-3540d9623195-d85e-4ee9-9f2b-cf0029d522ea12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3540HEPARIN SODIUM INJECTION, SOLUTION [SANDOZ INC.]4Current NDC, 2 package rows20250226_1c634e53-44d6-cdcd-e063-6294a90a92e9.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
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
ndc (product): 0781-3540
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 SolutionPSN1c634e53-44d6-cdcd-e063-6294a90a92e94
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionPSN1c634e53-44d6-cdcd-e063-6294a90a92e94
1361574heparin sodium, porcine 20,000 UNT/ML Injectable SolutionPSN1c634e53-44d6-cdcd-e063-6294a90a92e94
1658647heparin sodium, porcine 2000 UNT in 2 ML InjectionPSN1c634e53-44d6-cdcd-e063-6294a90a92e94
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionPSN1c634e53-44d6-cdcd-e063-6294a90a92e94
16586472 ML heparin sodium, porcine 1000 UNT/ML InjectionSCD1c634e53-44d6-cdcd-e063-6294a90a92e94
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionSCD1c634e53-44d6-cdcd-e063-6294a90a92e94
1362831heparin sodium, porcine 10000 UNT/ML Injectable SolutionSCD1c634e53-44d6-cdcd-e063-6294a90a92e94
1361574heparin sodium, porcine 20000 UNT/ML Injectable SolutionSCD1c634e53-44d6-cdcd-e063-6294a90a92e94
1361615heparin sodium, porcine 5000 UNT/ML Injectable SolutionSCD1c634e53-44d6-cdcd-e063-6294a90a92e94
1362831heparin sodium, porcine 10,000 UNT/ML Injectable SolutionSY1c634e53-44d6-cdcd-e063-6294a90a92e94
1361574heparin sodium, porcine 20,000 UNT/ML Injectable SolutionSY1c634e53-44d6-cdcd-e063-6294a90a92e94
1658647heparin sodium, porcine 2000 UNT per 2 ML InjectionSY1c634e53-44d6-cdcd-e063-6294a90a92e94
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionPSN4c118b39-cb4e-31a9-e063-6394a90a41b01
1361226heparin sodium, porcine 1000 UNT/ML Injectable SolutionSCD4c118b39-cb4e-31a9-e063-6394a90a41b01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0781-3540-100078135401010 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
0781-3540-250078135402525 VIAL, MULTI-DOSE in 1 CARTON (0781-3540-25) / 10 mL in 1 VIAL, MULTI-DOSE (0781-3540-10) 2024-09-16NoNoCurrent