Home NDC 11797-154 fondaparinux sodium
Product NDC 11797-154
11-digit product format 117970154
Labeler code 11797
Product ID 11797-154_714aaf0c-95ac-4de9-b8d2-5fdcd1365804
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fondaparinux sodium
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Italfarmaco S.p.A
Application ANDA208615
Marketing category ANDA
Marketing start 2019-02-06
Substance FONDAPARINUX SODIUM
Active strength 2.5 mg/.5mL
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208615-001 FONDAPARINUX SODIUM FONDAPARINUX SODIUM 2.5MG/0.5ML (2.5MG/0.5ML) SOLUTION / SUBCUTANEOUS AP 2018-11-14 A208615-002 FONDAPARINUX SODIUM FONDAPARINUX SODIUM 5MG/0.4ML (5MG/0.4ML) SOLUTION / SUBCUTANEOUS AP 2018-11-14 A208615-003 FONDAPARINUX SODIUM FONDAPARINUX SODIUM 7.5MG/0.6ML (7.5MG/0.6ML) SOLUTION / SUBCUTANEOUS AP 2018-11-14 A208615-004 FONDAPARINUX SODIUM FONDAPARINUX SODIUM 10MG/0.8ML (10MG/0.8ML) SOLUTION / SUBCUTANEOUS AP 2018-11-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A208615-001 FONDAPARINUX SODIUM 2.5MG/0.5ML (2.5MG/0.5ML) SOLUTION / SUBCUTANEOUS AP 2018-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208615-002 FONDAPARINUX SODIUM 5MG/0.4ML (5MG/0.4ML) SOLUTION / SUBCUTANEOUS AP 2018-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208615-003 FONDAPARINUX SODIUM 7.5MG/0.6ML (7.5MG/0.6ML) SOLUTION / SUBCUTANEOUS AP 2018-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208615-004 FONDAPARINUX SODIUM 10MG/0.8ML (10MG/0.8ML) SOLUTION / SUBCUTANEOUS AP 2018-11-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208615-001 FONDAPARINUX SODIUM 2.5MG/0.5ML SOLUTION / SUBCUTANEOUS AP 2018-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208615-002 FONDAPARINUX SODIUM 5MG/0.4ML SOLUTION / SUBCUTANEOUS AP 2018-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208615-003 FONDAPARINUX SODIUM 7.5MG/0.6ML SOLUTION / SUBCUTANEOUS AP 2018-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208615-004 FONDAPARINUX SODIUM 10MG/0.8ML SOLUTION / SUBCUTANEOUS AP 2018-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208615-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208615-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208615-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208615-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208615-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208615-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208615-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208615-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208615-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208615-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208615-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208615-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208615-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208615-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208615-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208615-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208615-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208615-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208615-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208615-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208615-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208615-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208615-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208615-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208615-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208615-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208615-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208615-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208615-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208615-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208615-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208615-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2018-11-14 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
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 2.5 mg/.5mL
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11797-154-02 fondaparinux sodium 0.5 mL in 1 SYRINGE INJECTION, SOLUTION 0.5 11 11797-154-06 fondaparinux sodium 10 in 1 CARTON INJECTION, SOLUTION 10 11 11797-154-09 fondaparinux sodium 2 in 1 CARTON INJECTION, SOLUTION 2 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11797-154 FONDAPARINUX SODIUM INJECTION, SOLUTION [ITALFARMACO S.P.A] 11 Current NDC, Legacy NDC, 3 package rows 20210105_58789e3d-e5bc-4c2e-a527-495a252fcecd.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 · 2 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 11797-154-02 11797015402 0.5 mL in 1 SYRINGE 0.5 ml Historical 11797-154-06 11797015406 10 SYRINGE in 1 CARTON (11797-154-06) / .5 mL in 1 SYRINGE (11797-154-02) 10 syringe 2019-02-06 0000-00-00 No No Current 11797-154-09 11797015409 2 SYRINGE in 1 CARTON (11797-154-09) / .5 mL in 1 SYRINGE (11797-154-02) 2 syringe 2019-02-06 0000-00-00 No No Current