Fondaparinux Sodium

Product NDC
0781-3454
11-digit product format
007813454
Labeler code
0781
Product ID
0781-3454_3d5a4b69-462b-7e51-e063-6294a90a0721
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fondaparinux Sodium
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Sandoz Inc.
Application
ANDA206812
Marketing category
ANDA
Marketing start
2019-06-18
Substance
FONDAPARINUX SODIUM
Active strength
5 mg/.4mL
Pharmacologic classes
Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]
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
A206812-001FONDAPARINUX SODIUMFONDAPARINUX SODIUM2.5MG/0.5ML (2.5MG/0.5ML)SOLUTION / SUBCUTANEOUS2018-05-15
A206812-002FONDAPARINUX SODIUMFONDAPARINUX SODIUM5MG/0.4ML (5MG/0.4ML)SOLUTION / SUBCUTANEOUS2018-05-15
A206812-003FONDAPARINUX SODIUMFONDAPARINUX SODIUM7.5MG/0.6ML (7.5MG/0.6ML)SOLUTION / SUBCUTANEOUS2018-05-15
A206812-004FONDAPARINUX SODIUMFONDAPARINUX SODIUM10MG/0.8ML (10MG/0.8ML)SOLUTION / SUBCUTANEOUS2018-05-15

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 06:07:402026-07A206812-001FONDAPARINUX SODIUM2.5MG/0.5ML (2.5MG/0.5ML)SOLUTION / SUBCUTANEOUS2018-05-15caaa826d4ba7…
2026-08-18 06:07:402026-07A206812-002FONDAPARINUX SODIUM5MG/0.4ML (5MG/0.4ML)SOLUTION / SUBCUTANEOUS2018-05-15caaa826d4ba7…
2026-08-18 06:07:402026-07A206812-003FONDAPARINUX SODIUM7.5MG/0.6ML (7.5MG/0.6ML)SOLUTION / SUBCUTANEOUS2018-05-15caaa826d4ba7…
2026-08-18 06:07:402026-07A206812-004FONDAPARINUX SODIUM10MG/0.8ML (10MG/0.8ML)SOLUTION / SUBCUTANEOUS2018-05-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206812-001FONDAPARINUX SODIUM2.5MG/0.5MLSOLUTION / SUBCUTANEOUSAP2018-05-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206812-002FONDAPARINUX SODIUM5MG/0.4MLSOLUTION / SUBCUTANEOUSAP2018-05-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206812-003FONDAPARINUX SODIUM7.5MG/0.6MLSOLUTION / SUBCUTANEOUSAP2018-05-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206812-004FONDAPARINUX SODIUM10MG/0.8MLSOLUTION / SUBCUTANEOUSAP2018-05-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206812-001FONDAPARINUX SODIUM2.5MG/0.5MLINJECTABLE / SUBCUTANEOUSAP2018-05-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206812-002FONDAPARINUX SODIUM5MG/0.4MLINJECTABLE / SUBCUTANEOUSAP2018-05-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206812-003FONDAPARINUX SODIUM7.5MG/0.6MLINJECTABLE / SUBCUTANEOUSAP2018-05-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206812-004FONDAPARINUX SODIUM10MG/0.8MLINJECTABLE / SUBCUTANEOUSAP2018-05-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A206812-001FONDAPARINUX SODIUM2.5MG/0.5MLINJECTABLE / SUBCUTANEOUSAP2018-05-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206812-002FONDAPARINUX SODIUM5MG/0.4MLINJECTABLE / SUBCUTANEOUSAP2018-05-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206812-003FONDAPARINUX SODIUM7.5MG/0.6MLINJECTABLE / SUBCUTANEOUSAP2018-05-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206812-004FONDAPARINUX SODIUM10MG/0.8MLINJECTABLE / SUBCUTANEOUSAP2018-05-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206812-001FONDAPARINUX SODIUM2.5MG/0.5MLINJECTABLE / SUBCUTANEOUSAP2018-05-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206812-002FONDAPARINUX SODIUM5MG/0.4MLINJECTABLE / SUBCUTANEOUSAP2018-05-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206812-003FONDAPARINUX SODIUM7.5MG/0.6MLINJECTABLE / SUBCUTANEOUSAP2018-05-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206812-004FONDAPARINUX SODIUM10MG/0.8MLINJECTABLE / SUBCUTANEOUSAP2018-05-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206812-001FONDAPARINUX SODIUM2.5MG/0.5MLINJECTABLE / SUBCUTANEOUSAP2018-05-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206812-002FONDAPARINUX SODIUM5MG/0.4MLINJECTABLE / SUBCUTANEOUSAP2018-05-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206812-003FONDAPARINUX SODIUM7.5MG/0.6MLINJECTABLE / SUBCUTANEOUSAP2018-05-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206812-004FONDAPARINUX SODIUM10MG/0.8MLINJECTABLE / SUBCUTANEOUSAP2018-05-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206812-001FONDAPARINUX SODIUM2.5MG/0.5MLINJECTABLE / SUBCUTANEOUSAP2018-05-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206812-002FONDAPARINUX SODIUM5MG/0.4MLINJECTABLE / SUBCUTANEOUSAP2018-05-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206812-003FONDAPARINUX SODIUM7.5MG/0.6MLINJECTABLE / SUBCUTANEOUSAP2018-05-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206812-004FONDAPARINUX SODIUM10MG/0.8MLINJECTABLE / SUBCUTANEOUSAP2018-05-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206812-001FONDAPARINUX SODIUM2.5MG/0.5MLINJECTABLE / SUBCUTANEOUSAP2018-05-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206812-002FONDAPARINUX SODIUM5MG/0.4MLINJECTABLE / SUBCUTANEOUSAP2018-05-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206812-003FONDAPARINUX SODIUM7.5MG/0.6MLINJECTABLE / SUBCUTANEOUSAP2018-05-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206812-004FONDAPARINUX SODIUM10MG/0.8MLINJECTABLE / SUBCUTANEOUSAP2018-05-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206812-001FONDAPARINUX SODIUM2.5MG/0.5MLINJECTABLE / SUBCUTANEOUSAP2018-05-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206812-002FONDAPARINUX SODIUM5MG/0.4MLINJECTABLE / SUBCUTANEOUSAP2018-05-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206812-003FONDAPARINUX SODIUM7.5MG/0.6MLINJECTABLE / SUBCUTANEOUSAP2018-05-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206812-004FONDAPARINUX SODIUM10MG/0.8MLINJECTABLE / SUBCUTANEOUSAP2018-05-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206812-001FONDAPARINUX SODIUM2.5MG/0.5MLINJECTABLE / SUBCUTANEOUSAP2018-05-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206812-002FONDAPARINUX SODIUM5MG/0.4MLINJECTABLE / SUBCUTANEOUSAP2018-05-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206812-003FONDAPARINUX SODIUM7.5MG/0.6MLINJECTABLE / SUBCUTANEOUSAP2018-05-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206812-004FONDAPARINUX SODIUM10MG/0.8MLINJECTABLE / SUBCUTANEOUSAP2018-05-15d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206812-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206812-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206812-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206812-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206812-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206812-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206812-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206812-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206812-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206812-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206812-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206812-004AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206812-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206812-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206812-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206812-004AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206812-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206812-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206812-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206812-004AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206812-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206812-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206812-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206812-004AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206812-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206812-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206812-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206812-004AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206812-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206812-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206812-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206812-004AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206812-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206812-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206812-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206812-004AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206812-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206812-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206812-003AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206812-004AP1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Fondaparinux Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FONDAPARINUX SODIUM5 mg/.4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X0Q6N9USOZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861356Internal RxNorm lookup
861360Internal RxNorm lookup
861363Internal RxNorm lookup
861365Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
baa50757-a927-4d56-a933-5d7798fe6ab0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
03ac78a4-5655-4d9a-b2f1-a0919f833364Product name520250818

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3454-12Fondaparinux Sodium2 in 1 CARTONINJECTION218
0781-3454-94Fondaparinux Sodium0.4 mL in 1 SYRINGEINJECTION0.418
0781-3454-95Fondaparinux Sodium10 in 1 CARTONINJECTION1018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3454FONDAPARINUX SODIUM INJECTION [SANDOZ INC.]17Current NDC, Legacy NDC, 3 package rows20250302_baa50757-a927-4d56-a933-5d7798fe6ab0.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
Fondaparinux SodiumFONDAPARINUX SODIUMSandoz Inc.baa50757-a927-4d56-a933-5d7798fe6ab02025-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206812
application number: ANDA206812
ndc (product): 0781-3454

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861356fondaparinux sodium 10 MG in 0.8 ML Prefilled SyringePSNbaa50757-a927-4d56-a933-5d7798fe6ab018
861360fondaparinux sodium 2.5 MG in 0.5 ML Prefilled SyringePSNbaa50757-a927-4d56-a933-5d7798fe6ab018
861363fondaparinux sodium 5 MG in 0.4 ML Prefilled SyringePSNbaa50757-a927-4d56-a933-5d7798fe6ab018
861365fondaparinux sodium 7.5 MG in 0.6 ML Prefilled SyringePSNbaa50757-a927-4d56-a933-5d7798fe6ab018
8613630.4 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCDbaa50757-a927-4d56-a933-5d7798fe6ab018
8613600.5 ML fondaparinux sodium 5 MG/ML Prefilled SyringeSCDbaa50757-a927-4d56-a933-5d7798fe6ab018
8613650.6 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCDbaa50757-a927-4d56-a933-5d7798fe6ab018
8613560.8 ML fondaparinux sodium 12.5 MG/ML Prefilled SyringeSCDbaa50757-a927-4d56-a933-5d7798fe6ab018
861356fondaparinux sodium 10 MG per 0.8 ML Prefilled SyringeSYbaa50757-a927-4d56-a933-5d7798fe6ab018
861360fondaparinux sodium 2.5 MG per 0.5 ML Prefilled SyringeSYbaa50757-a927-4d56-a933-5d7798fe6ab018
861363fondaparinux sodium 5 MG per 0.4 ML Prefilled SyringeSYbaa50757-a927-4d56-a933-5d7798fe6ab018
861365fondaparinux sodium 7.5 MG per 0.6 ML Prefilled SyringeSYbaa50757-a927-4d56-a933-5d7798fe6ab018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-3454-12007813454122 SYRINGE in 1 CARTON (0781-3454-12) / .4 mL in 1 SYRINGE (0781-3454-94) 2 syringe2019-06-180000-00-00NoNoCurrent
0781-3454-94007813454940.4 mL in 1 SYRINGE0.4 mlHistorical
0781-3454-950078134549510 SYRINGE in 1 CARTON (0781-3454-95) / .4 mL in 1 SYRINGE (0781-3454-94) 10 syringe2019-06-180000-00-00NoNoCurrent