Heparin Sodium in Dextrose

Product NDC
0264-9577
11-digit product format
002649577
Labeler code
0264
Product ID
0264-9577_f712c321-04c0-49b5-93bd-59928483abbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heparin Sodium and Dextrose
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA019952
Marketing category
NDA
Marketing start
1992-07-20
Substance
HEPARIN SODIUM; DEXTROSE MONOHYDRATE
Active strength
5000; 5 [USP'U]/100mL; g/100mL
Pharmacologic classes
Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N019952-001HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER4,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS1992-07-20c2088c7a36db…
2026-10-15 13:18:302026-09N019952-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20c2088c7a36db…
2026-10-15 13:18:302026-09N019952-005HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-20c2088c7a36db…
2026-09-14 22:38:342026-08N019952-001HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER4,000 UNITS/100MLINJECTABLE / INJECTIONRLD, RS1992-07-2084e616aacf4f…
2026-09-14 22:38:342026-08N019952-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-2084e616aacf4f…
2026-09-14 22:38:342026-08N019952-005HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAPRLD, RS1992-07-2084e616aacf4f…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N019952-004AP1c2088c7a36db…
2026-10-15 13:18:302026-09N019952-005AP1c2088c7a36db…
2026-09-14 22:38:342026-08N019952-004AP184e616aacf4f…
2026-09-14 22:38:342026-08N019952-005AP184e616aacf4f…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Heparin Sodium in Dextrose
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEPARIN SODIUM5000 [USP'U]/100mL
DEXTROSE MONOHYDRATE5 g/100mL

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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
05193eb6-d122-ab0b-603b-d9dd92599836Product name220210204
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
2e5437ef-ff80-c9c2-2f66-5b7c771080beProduct name920180201
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
ae28a785-50d8-477d-a268-dffdfdd7504bProduct name120150305
0c878822-66ca-456d-c17d-0894b04fa473Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0264-9577-10Heparin Sodium in Dextrose24 in 1 CASEINJECTION2436
0264-9577-10Heparin Sodium in Dextrose500 mL in 1 CONTAINERINJECTION50036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-9577-10ML - Milliliter0264-9577b97bcd3e-a68b-4755-bd96-7e16259c9bfd12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-9577HEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE) INJECTION [B. BRAUN MEDICAL INC.]36Current NDC, Legacy NDC, 2 package rows20240823_92a6f533-1a3d-4734-b413-d245592454e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1361607heparin sodium, porcine 20,000 UNT in 500 ML InjectionPSN92a6f533-1a3d-4734-b413-d245592454e336
1658717heparin sodium, porcine 25,000 UNT in 250 ML InjectionPSN92a6f533-1a3d-4734-b413-d245592454e336
1659195heparin sodium, porcine 25,000 UNT in 500 ML InjectionPSN92a6f533-1a3d-4734-b413-d245592454e336
1658717250 ML heparin sodium, porcine 100 UNT/ML InjectionSCD92a6f533-1a3d-4734-b413-d245592454e336
1361607500 ML heparin sodium, porcine 40 UNT/ML InjectionSCD92a6f533-1a3d-4734-b413-d245592454e336
1659195500 ML heparin sodium, porcine 50 UNT/ML InjectionSCD92a6f533-1a3d-4734-b413-d245592454e336
1361607heparin sodium, porcine 20,000 UNT per 500 ML InjectionSY92a6f533-1a3d-4734-b413-d245592454e336
1658717heparin sodium, porcine 25,000 UNT per 250 ML InjectionSY92a6f533-1a3d-4734-b413-d245592454e336
1659195heparin sodium, porcine 25,000 UNT per 500 ML InjectionSY92a6f533-1a3d-4734-b413-d245592454e336

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-9577-100026495771024 CONTAINER in 1 CASE (0264-9577-10) / 500 mL in 1 CONTAINER24 container1992-07-200000-00-00NoNoCurrent