Home NDC 43598-606 Fondaparinux Sodium
Product NDC 43598-606
11-digit product format 435980606
Labeler code 43598
Product ID 43598-606_a0391e02-8a69-6aa6-d687-f740a2a44bfa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fondaparinux Sodium
Dosage form INJECTION
Route SUBCUTANEOUS
Labeler Dr. Reddy's Laboratories Inc.
Application ANDA091316
Marketing category ANDA
Marketing start 2017-07-27
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43598-606-10 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43598-606-02 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43598-606-10 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43598-606-02 f5e01cc5f278…a2eaf40c39c3…
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 A091316-001 FONDAPARINUX SODIUM FONDAPARINUX SODIUM 2.5MG/0.5ML (2.5MG/0.5ML) SOLUTION / SUBCUTANEOUS AP 2011-07-11 A091316-002 FONDAPARINUX SODIUM FONDAPARINUX SODIUM 5MG/0.4ML (5MG/0.4ML) SOLUTION / SUBCUTANEOUS AP 2011-07-11 A091316-003 FONDAPARINUX SODIUM FONDAPARINUX SODIUM 7.5MG/0.6ML (7.5MG/0.6ML) SOLUTION / SUBCUTANEOUS AP 2011-07-11 A091316-004 FONDAPARINUX SODIUM FONDAPARINUX SODIUM 10MG/0.8ML (10MG/0.8ML) SOLUTION / SUBCUTANEOUS AP 2011-07-11
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 A091316-001 FONDAPARINUX SODIUM 2.5MG/0.5ML (2.5MG/0.5ML) SOLUTION / SUBCUTANEOUS AP 2011-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091316-002 FONDAPARINUX SODIUM 5MG/0.4ML (5MG/0.4ML) SOLUTION / SUBCUTANEOUS AP 2011-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091316-003 FONDAPARINUX SODIUM 7.5MG/0.6ML (7.5MG/0.6ML) SOLUTION / SUBCUTANEOUS AP 2011-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091316-004 FONDAPARINUX SODIUM 10MG/0.8ML (10MG/0.8ML) SOLUTION / SUBCUTANEOUS AP 2011-07-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091316-001 FONDAPARINUX SODIUM 2.5MG/0.5ML SOLUTION / SUBCUTANEOUS AP 2011-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091316-002 FONDAPARINUX SODIUM 5MG/0.4ML SOLUTION / SUBCUTANEOUS AP 2011-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091316-003 FONDAPARINUX SODIUM 7.5MG/0.6ML SOLUTION / SUBCUTANEOUS AP 2011-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091316-004 FONDAPARINUX SODIUM 10MG/0.8ML SOLUTION / SUBCUTANEOUS AP 2011-07-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091316-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091316-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091316-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091316-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091316-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091316-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091316-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091316-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091316-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091316-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091316-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091316-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091316-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091316-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091316-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091316-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091316-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091316-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091316-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091316-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091316-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091316-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091316-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091316-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091316-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091316-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091316-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091316-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091316-001 FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091316-002 FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091316-003 FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091316-004 FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE / SUBCUTANEOUS AP 2011-07-11 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-606 FONDAPARINUX SODIUM INJECTION [DR. REDDY'S LABORATORIES INC.] 5 Legacy NDC 20221224_8a27f341-f612-de72-8c1f-3fd977905de0.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43598-606-02 43598060602 2 SYRINGE in 1 CARTON (43598-606-02) > .8 mL in 1 SYRINGE (43598-606-11) 2 syringe 2017-07-27 0000-00-00 No No Current 43598-606-10 43598060610 10 SYRINGE in 1 CARTON (43598-606-10) > .8 mL in 1 SYRINGE (43598-606-11) 10 syringe 2017-07-27 0000-00-00 No No Current