Heparin Sodium in Dextrose

Product NDC
50090-4537
11-digit product format
500904537
Labeler code
50090
Product ID
50090-4537_ad1df03e-1e23-4af6-8893-eebeeb79108a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium and Dextrose
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
A-S Medication Solutions
Application
NDA019952
Marketing category
NDA
Marketing start
1992-07-20
Marketing end
0000-00-00
Substance
HEPARIN SODIUM; DEXTROSE MONOHYDRATE
Active strength
5000 [USP'U]/100mL; g/100mL
Pharmacologic classes
Anti-coagulant [EPC],Heparin [CS],Unfractionated Heparin [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-4537DDiscontinued by firm2026-08-17
excluded packagepackage50090-453750090-4537-0DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 20 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-4537-0DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4537-0DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4537-0DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4537-0DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4537-0DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4537-0DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4537-0DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4537-0DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4537-0DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4537-0IInactivated by FDA1332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019952-001HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERHEPARIN SODIUM4,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS1992-07-20
N019952-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERHEPARIN SODIUM5,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20
N019952-005HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERHEPARIN SODIUM10,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019952-004AP
N019952-005AP

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019952-001HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER4,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS1992-07-20caaa826d4ba7…
2026-08-18 06:07:402026-07N019952-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20caaa826d4ba7…
2026-08-18 06:07:402026-07N019952-005HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019952-001HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER4,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS1992-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019952-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019952-005HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019952-001HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER4,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS1992-07-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019952-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019952-005HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N019952-001HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER4,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS1992-07-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019952-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019952-005HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019952-001HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER4,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS1992-07-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019952-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019952-005HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019952-001HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER4,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS1992-07-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019952-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019952-005HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019952-001HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER4,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS1992-07-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019952-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019952-005HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019952-001HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER4,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS1992-07-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019952-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019952-005HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019952-001HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER4,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS1992-07-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019952-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019952-005HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019952-001HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER4,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS1992-07-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019952-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019952-005HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019952-001HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER4,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS1992-07-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N019952-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N019952-005HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019952-001HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER4,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS1992-07-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019952-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019952-005HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019952-001HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER4,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS1992-07-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019952-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019952-005HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019952-001HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER4,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS1992-07-201e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 95 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N019952-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N019952-005AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019952-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019952-005AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019952-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019952-005AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019952-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019952-005AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019952-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019952-005AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019952-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019952-005AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019952-004AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019952-005AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019952-004AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019952-005AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019952-004AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019952-005AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019952-004AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019952-005AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019952-004AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019952-005AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019952-004AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019952-005AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019952-004AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019952-005AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019952-004AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019952-005AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019952-004AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019952-005AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019952-004AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019952-005AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019952-004AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019952-005AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019952-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019952-004AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019952-005AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019952-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019952-004AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019952-005AP174a2ff9319b5…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4537-0ML - Milliliter50090-4537b2bf299c-91e0-439c-8928-988a5e7eb7f112022-07-06

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Heparin Sodium in DextroseHEPARIN SODIUM AND DEXTROSEB. Braun Medical Inc.92a6f533-1a3d-4734-b413-d245592454e32023-07-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 019952
application number: NDA019952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4537-050090453700500 mL in 1 CONTAINER (50090-4537-0) 500 ml2019-09-190000-00-00NoNoCurrent