Fondaparinux Sodium
- Product NDC
- 0781-3465
- 11-digit product format
- 007813465
- Labeler code
- 0781
- Product ID
- 0781-3465_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
- 7.5 mg/.6mL
- Pharmacologic classes
- Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| 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.
| 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 | 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… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206812-001 | FONDAPARINUX SODIUM | 2.5MG/0.5ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206812-002 | FONDAPARINUX SODIUM | 5MG/0.4ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206812-003 | FONDAPARINUX SODIUM | 7.5MG/0.6ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206812-004 | FONDAPARINUX SODIUM | 10MG/0.8ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A206812-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206812-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206812-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206812-004 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206812-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206812-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206812-003 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206812-004 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206812-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206812-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206812-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206812-004 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206812-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206812-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206812-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206812-004 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206812-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206812-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206812-003 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206812-004 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206812-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206812-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206812-003 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206812-004 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206812-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206812-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206812-003 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206812-004 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206812-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206812-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206812-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206812-004 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206812-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206812-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206812-003 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206812-004 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A206812-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206812-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206812-003 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206812-004 | AP | 1 | d06236e962d9… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fondaparinux Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FONDAPARINUX SODIUM | 7.5 mg/.6mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| X0Q6N9USOZ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| baa50757-a927-4d56-a933-5d7798fe6ab0 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 03ac78a4-5655-4d9a-b2f1-a0919f833364 | Product name | 5 | 20250818 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0781-3465-12 | Fondaparinux Sodium | 2 in 1 CARTON | INJECTION | 2 | 18 | |
| 0781-3465-94 | Fondaparinux Sodium | 0.6 mL in 1 SYRINGE | INJECTION | 0.6 | 18 | |
| 0781-3465-95 | Fondaparinux Sodium | 10 in 1 CARTON | INJECTION | 10 | 18 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Fondaparinux Sodium | FONDAPARINUX SODIUM | Sandoz Inc. | baa50757-a927-4d56-a933-5d7798fe6ab0 | 2025-08-27 | Boxed warning, Warnings, Adverse reactions | 206812 ANDA206812 0781-3465 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 861356 | fondaparinux sodium 10 MG in 0.8 ML Prefilled Syringe | PSN | baa50757-a927-4d56-a933-5d7798fe6ab0 | 18 |
| 861360 | fondaparinux sodium 2.5 MG in 0.5 ML Prefilled Syringe | PSN | baa50757-a927-4d56-a933-5d7798fe6ab0 | 18 |
| 861363 | fondaparinux sodium 5 MG in 0.4 ML Prefilled Syringe | PSN | baa50757-a927-4d56-a933-5d7798fe6ab0 | 18 |
| 861365 | fondaparinux sodium 7.5 MG in 0.6 ML Prefilled Syringe | PSN | baa50757-a927-4d56-a933-5d7798fe6ab0 | 18 |
| 861363 | 0.4 ML fondaparinux sodium 12.5 MG/ML Prefilled Syringe | SCD | baa50757-a927-4d56-a933-5d7798fe6ab0 | 18 |
| 861360 | 0.5 ML fondaparinux sodium 5 MG/ML Prefilled Syringe | SCD | baa50757-a927-4d56-a933-5d7798fe6ab0 | 18 |
| 861365 | 0.6 ML fondaparinux sodium 12.5 MG/ML Prefilled Syringe | SCD | baa50757-a927-4d56-a933-5d7798fe6ab0 | 18 |
| 861356 | 0.8 ML fondaparinux sodium 12.5 MG/ML Prefilled Syringe | SCD | baa50757-a927-4d56-a933-5d7798fe6ab0 | 18 |
| 861356 | fondaparinux sodium 10 MG per 0.8 ML Prefilled Syringe | SY | baa50757-a927-4d56-a933-5d7798fe6ab0 | 18 |
| 861360 | fondaparinux sodium 2.5 MG per 0.5 ML Prefilled Syringe | SY | baa50757-a927-4d56-a933-5d7798fe6ab0 | 18 |
| 861363 | fondaparinux sodium 5 MG per 0.4 ML Prefilled Syringe | SY | baa50757-a927-4d56-a933-5d7798fe6ab0 | 18 |
| 861365 | fondaparinux sodium 7.5 MG per 0.6 ML Prefilled Syringe | SY | baa50757-a927-4d56-a933-5d7798fe6ab0 | 18 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0781-3465-12 | 00781346512 | 2 SYRINGE in 1 CARTON (0781-3465-12) / .6 mL in 1 SYRINGE (0781-3465-94) | 2 syringe | 2019-06-18 | 0000-00-00 | No | No | Current |
| 0781-3465-94 | 00781346594 | 0.6 mL in 1 SYRINGE | 0.6 ml | Historical | ||||
| 0781-3465-95 | 00781346595 | 10 SYRINGE in 1 CARTON (0781-3465-95) / .6 mL in 1 SYRINGE (0781-3465-94) | 10 syringe | 2019-06-18 | 0000-00-00 | No | No | Current |