Heparin Sodium and Dextrose

Product NDC
0409-4520
11-digit product format
004094520
Labeler code
0409
Product ID
0409-4520_b2a0ec6b-eee0-46b9-9e8a-ae2442e30771
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HEPARIN SODIUM
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA019339
Marketing category
NDA
Marketing start
2022-12-12
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
2027-12-31
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
N019339-001HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERHEPARIN SODIUM5,000 UNITS/100MLINJECTABLE / INJECTION1985-03-27
N019339-002HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERHEPARIN SODIUM10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-27
N019339-003HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERHEPARIN SODIUM10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-27
N019339-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINERHEPARIN SODIUM5,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N019339-002AP
N019339-003AP
N019339-004AP

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 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019339-001HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTION1985-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07N019339-002HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07N019339-003HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07N019339-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019339-001HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTION1985-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019339-002HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019339-003HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019339-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019339-001HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTION1985-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019339-002HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019339-003HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019339-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N019339-001HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTION1985-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019339-002HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019339-003HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019339-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019339-001HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTION1985-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019339-002HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019339-003HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019339-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019339-001HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTION1985-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019339-002HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019339-003HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019339-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019339-001HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTION1985-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019339-002HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019339-003HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019339-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019339-001HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTION1985-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019339-002HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019339-003HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019339-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019339-001HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTION1985-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019339-002HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019339-003HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019339-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019339-001HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTION1985-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019339-002HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019339-003HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER10,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019339-004HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER5,000 UNITS/100MLINJECTABLE / INJECTIONAP1985-03-27d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N019339-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N019339-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N019339-004AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019339-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019339-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019339-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019339-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019339-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019339-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019339-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019339-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019339-004AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019339-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019339-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019339-004AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019339-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019339-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019339-004AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019339-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019339-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019339-004AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019339-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019339-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019339-004AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019339-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019339-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019339-004AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019339-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019339-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019339-004AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019339-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019339-003AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019339-004AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019339-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019339-003AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019339-004AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019339-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019339-003AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019339-004AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019339-002AP11e350fbaab3a…

Additional Listing Data#

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

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eede8a0c-5ae6-4166-84b3-12081405f08eAvailable 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
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
0409-4520-02Heparin Sodium and Dextrose250 mL in 1 BAGINJECTION, SOLUTION25035
0409-4520-30Heparin Sodium and Dextrose30 in 1 CASEINJECTION, SOLUTION3035
0409-4520-30Heparin Sodium and Dextrose1 in 1 POUCHINJECTION, SOLUTION135

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4520-02ML - Milliliter0409-4520f5c76cd4-f5f9-4c80-a432-0d369f652ddb12023-01-09
0409-4520-30ML - Milliliter0409-452046269ff8-ea8d-46b3-8eff-8f08f30b655d12023-01-09

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4520HEPARIN SODIUM AND DEXTROSE (HEPARIN SODIUM) INJECTION, SOLUTION [HOSPIRA, INC.]31Current NDC, Legacy NDC, 3 package rows20241201_eede8a0c-5ae6-4166-84b3-12081405f08e.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Heparin Sodium and DextroseHEPARIN SODIUMHospira, Inc.eede8a0c-5ae6-4166-84b3-12081405f08e2026-05-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 019339
application number: NDA019339
ndc (product): 0409-4520

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658717heparin sodium, porcine 25,000 UNT in 250 ML InjectionPSNeede8a0c-5ae6-4166-84b3-12081405f08e35
1658717250 ML heparin sodium, porcine 100 UNT/ML InjectionSCDeede8a0c-5ae6-4166-84b3-12081405f08e35
1658717heparin sodium, porcine 25,000 UNT per 250 ML InjectionSYeede8a0c-5ae6-4166-84b3-12081405f08e35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-4520-0200409452002250 mL in 1 BAG250 mlHistorical
0409-4520-300040945203030 POUCH in 1 CASE (0409-4520-30) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0409-4520-02) 30 pouch2022-12-120000-00-00NoNoCurrent