Heparin Sodium in Sodium Chloride

Product NDC
0264-3462
11-digit product format
002643462
Labeler code
0264
Product ID
0264-3462_3d89e31c-d6f4-4b90-a97f-a6eb06b0d009
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium in Sodium Chloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA019953
Marketing category
NDA
Marketing start
2025-07-18
Substance
HEPARIN SODIUM
Active strength
10000 [USP'U]/100mL
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019953-001HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERHEPARIN SODIUM200 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20
N019953-002HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERHEPARIN SODIUM200 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2023-12-15
N019953-003HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERHEPARIN SODIUM5,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2025-03-25
N019953-004HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERHEPARIN SODIUM10,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2025-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019953-001AP

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 2 · 70 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019953-001HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20caaa826d4ba7…
2026-08-18 06:07:402026-07N019953-002HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2023-12-15caaa826d4ba7…
2026-08-18 06:07:402026-07N019953-003HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2025-03-25caaa826d4ba7…
2026-08-18 06:07:402026-07N019953-004HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2025-03-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019953-001HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019953-002HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2023-12-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019953-003HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2025-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019953-004HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2025-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019953-001HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019953-002HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2023-12-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019953-003HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2025-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019953-004HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2025-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N019953-001HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019953-002HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2023-12-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019953-003HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2025-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019953-004HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2025-03-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019953-001HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019953-002HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2023-12-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019953-001HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019953-002HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2023-12-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019953-001HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019953-002HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2023-12-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019953-001HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019953-002HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2023-12-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019953-001HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019953-002HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2023-12-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019953-001HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019953-002HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2023-12-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019953-001HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N019953-002HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2023-12-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019953-001HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019953-002HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2023-12-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019953-001HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019953-002HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2023-12-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019953-001HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019953-002HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2023-12-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019953-001HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019953-002HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONRLD, RS2023-12-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019953-001HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019953-001HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-205d02ea3f76ae…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N019953-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019953-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019953-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019953-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019953-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019953-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019953-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019953-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019953-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019953-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019953-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019953-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019953-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019953-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019953-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019953-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019953-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019953-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019953-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019953-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019953-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019953-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N019953-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019953-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019953-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019953-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N019953-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N019953-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019953-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019953-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019953-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019953-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019953-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019953-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019953-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N019953-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N019953-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019953-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019953-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019953-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Heparin Sodium in Sodium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPARIN SODIUM10000 [USP'U]/100mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1658717Internal RxNorm lookup
1659195Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8b030692-fc66-4c53-85aa-6f865e635618Available 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
0264-3462-20Heparin Sodium in Sodium Chloride250 mL in 1 CONTAINERINJECTION2506
0264-3462-20Heparin Sodium in Sodium Chloride24 in 1 CASEINJECTION246

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-3462-20ML - Milliliter0264-3462f166868d-e169-40a0-9770-e454583e9fc612025-08-11

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Heparin Sodium in Sodium ChlorideHEPARIN SODIUM IN SODIUM CHLORIDEB. Braun Medical Inc.a3041c04-0ea8-4d36-81ce-c5091c9063162025-08-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 019953
application number: NDA019953
Heparin Sodium in Sodium ChlorideHEPARIN SODIUM IN SODIUM CHLORIDEB. Braun Medical Inc.8b030692-fc66-4c53-85aa-6f865e6356182025-07-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 019953
application number: NDA019953
ndc (product): 0264-3462

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658717heparin sodium, porcine 25,000 UNT in 250 ML InjectionPSN8b030692-fc66-4c53-85aa-6f865e6356186
1659195heparin sodium, porcine 25,000 UNT in 500 ML InjectionPSN8b030692-fc66-4c53-85aa-6f865e6356186
1658717250 ML heparin sodium, porcine 100 UNT/ML InjectionSCD8b030692-fc66-4c53-85aa-6f865e6356186
1659195500 ML heparin sodium, porcine 50 UNT/ML InjectionSCD8b030692-fc66-4c53-85aa-6f865e6356186
1658717heparin sodium, porcine 25,000 UNT per 250 ML InjectionSY8b030692-fc66-4c53-85aa-6f865e6356186
1659195heparin sodium, porcine 25,000 UNT per 500 ML InjectionSY8b030692-fc66-4c53-85aa-6f865e6356186

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0264-3462-200026434622024 CONTAINER in 1 CASE (0264-3462-20) / 250 mL in 1 CONTAINER24 container2025-07-18NoNoCurrent