Home NDC 0781-3476 Fondaparinux Sodium
Product NDC 0781-3476
11-digit product format 007813476
Labeler code 0781
Product ID 0781-3476_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 10 mg/.8mL
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 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206812-001 FONDAPARINUX SODIUM FONDAPARINUX SODIUM 2.5MG/0.5ML (2.5MG/0.5ML) SOLUTION / SUBCUTANEOUS 2018-05-15 A206812-002 FONDAPARINUX SODIUM FONDAPARINUX SODIUM 5MG/0.4ML (5MG/0.4ML) SOLUTION / SUBCUTANEOUS 2018-05-15 A206812-003 FONDAPARINUX SODIUM FONDAPARINUX SODIUM 7.5MG/0.6ML (7.5MG/0.6ML) SOLUTION / SUBCUTANEOUS 2018-05-15 A206812-004 FONDAPARINUX SODIUM FONDAPARINUX SODIUM 10MG/0.8ML (10MG/0.8ML) SOLUTION / SUBCUTANEOUS 2018-05-15
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 · 172 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A206812-001 FONDAPARINUX SODIUM 2.5MG/0.5ML (2.5MG/0.5ML) SOLUTION / SUBCUTANEOUS 2018-05-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206812-002 FONDAPARINUX SODIUM 5MG/0.4ML (5MG/0.4ML) SOLUTION / SUBCUTANEOUS 2018-05-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206812-003 FONDAPARINUX SODIUM 7.5MG/0.6ML (7.5MG/0.6ML) SOLUTION / SUBCUTANEOUS 2018-05-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206812-004 FONDAPARINUX SODIUM 10MG/0.8ML (10MG/0.8ML) SOLUTION / SUBCUTANEOUS 2018-05-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206812-001 FONDAPARINUX SODIUM 2.5MG/0.5ML (2.5MG/0.5ML) SOLUTION / SUBCUTANEOUS 2018-05-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206812-002 FONDAPARINUX SODIUM 5MG/0.4ML (5MG/0.4ML) SOLUTION / SUBCUTANEOUS 2018-05-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206812-003 FONDAPARINUX SODIUM 7.5MG/0.6ML (7.5MG/0.6ML) SOLUTION / SUBCUTANEOUS 2018-05-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206812-004 FONDAPARINUX SODIUM 10MG/0.8ML (10MG/0.8ML) SOLUTION / SUBCUTANEOUS 2018-05-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206812-001 FONDAPARINUX SODIUM 2.5MG/0.5ML SOLUTION / SUBCUTANEOUS AP 2018-05-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206812-002 FONDAPARINUX SODIUM 5MG/0.4ML SOLUTION / SUBCUTANEOUS AP 2018-05-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206812-003 FONDAPARINUX SODIUM 7.5MG/0.6ML SOLUTION / SUBCUTANEOUS AP 2018-05-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206812-004 FONDAPARINUX SODIUM 10MG/0.8ML SOLUTION / SUBCUTANEOUS AP 2018-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206812-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206812-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206812-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206812-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206812-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206812-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206812-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206812-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206812-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206812-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206812-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206812-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206812-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206812-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206812-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206812-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206812-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206812-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206812-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206812-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206812-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206812-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206812-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206812-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206812-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206812-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206812-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206812-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2018-05-15 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 160 observed states.
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 Fondaparinux Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FONDAPARINUX SODIUM 10 mg/.8mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X0Q6N9USOZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861356 Internal RxNorm lookup 861360 Internal RxNorm lookup 861363 Internal RxNorm lookup 861365 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0781-3476-12 Fondaparinux Sodium 2 in 1 CARTON INJECTION 2 18 0781-3476-94 Fondaparinux Sodium 0.8 mL in 1 SYRINGE INJECTION 0.8 18 0781-3476-95 Fondaparinux Sodium 10 in 1 CARTON INJECTION 10 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-3476 FONDAPARINUX SODIUM INJECTION [SANDOZ INC.] 17 Current NDC, Legacy NDC, 3 package rows 20250302_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0781-3476-12 00781347612 2 SYRINGE in 1 CARTON (0781-3476-12) / .8 mL in 1 SYRINGE (0781-3476-94) 2 syringe 2019-06-18 0000-00-00 No No Current 0781-3476-94 00781347694 0.8 mL in 1 SYRINGE 0.8 ml Historical 0781-3476-95 00781347695 10 SYRINGE in 1 CARTON (0781-3476-95) / .8 mL in 1 SYRINGE (0781-3476-94) 10 syringe 2019-06-18 0000-00-00 No No Current