Fondaparinux Sodium
- Product NDC
- 55111-679
- 11-digit product format
- 551110679
- Labeler code
- 55111
- Product ID
- 55111-679_2a3f9c6b-885b-843d-9cc8-3eb67395fbda
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fondaparinux Sodium
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Dr. Reddy's Laboratories Limited
- Application
- ANDA091316
- Marketing category
- ANDA
- Marketing start
- 2011-07-14
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fondaparinux Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FONDAPARINUX SODIUM | 5 mg/.4mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | X0Q6N9USOZ |
| Rxcui | 861356, 861360, 861363, 861365 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 03ac78a4-5655-4d9a-b2f1-a0919f833364 | Product name | 5 | 20250818 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55111-679-02 | Fondaparinux Sodium | 2 in 1 CARTON | INJECTION | 2 | 16 | |
| 55111-679-10 | Fondaparinux Sodium | 10 in 1 CARTON | INJECTION | 10 | 16 | |
| 55111-679-11 | Fondaparinux Sodium | 0.4 mL in 1 SYRINGE | INJECTION | 0.4 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55111-679-02 | ML - Milliliter | 55111-679 | 065efc44-afaa-44ba-825e-273e0dda51f1 | 1 | 2012-07-24 |
| 55111-679-10 | ML - Milliliter | 55111-679 | bc59fb63-dc71-42a6-a1da-b9fbb4d9143d | 1 | 2012-07-24 |
| 55111-679-11 | ML - Milliliter | 55111-679 | 960afbd9-8588-4eb6-b1d6-85c20374219b | 1 | 2015-07-20 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| fondaparinux sodium | ACTIVE INGREDIENT | X0Q6N9USOZ | FONDAPARINUX SODIUM INJECTION [DR. REDDY'S LABORATORIES LIMITED] | 10 | |
| fondaparinux | ACTIVE MOIETY | J177FOW5JL | FONDAPARINUX SODIUM INJECTION [DR. REDDY'S LABORATORIES LIMITED] | 10 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | FONDAPARINUX SODIUM INJECTION [DR. REDDY'S LABORATORIES LIMITED] | 10 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | FONDAPARINUX SODIUM INJECTION [DR. REDDY'S LABORATORIES LIMITED] | 10 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | FONDAPARINUX SODIUM INJECTION [DR. REDDY'S LABORATORIES LIMITED] | 10 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 861356 | fondaparinux sodium 10 MG in 0.8 ML Prefilled Syringe | PSN | 49e0d7bc-3f49-849b-c77c-98682d1c0d19 | 16 |
| 861360 | fondaparinux sodium 2.5 MG in 0.5 ML Prefilled Syringe | PSN | 49e0d7bc-3f49-849b-c77c-98682d1c0d19 | 16 |
| 861363 | fondaparinux sodium 5 MG in 0.4 ML Prefilled Syringe | PSN | 49e0d7bc-3f49-849b-c77c-98682d1c0d19 | 16 |
| 861365 | fondaparinux sodium 7.5 MG in 0.6 ML Prefilled Syringe | PSN | 49e0d7bc-3f49-849b-c77c-98682d1c0d19 | 16 |
| 861363 | 0.4 ML fondaparinux sodium 12.5 MG/ML Prefilled Syringe | SCD | 49e0d7bc-3f49-849b-c77c-98682d1c0d19 | 16 |
| 861360 | 0.5 ML fondaparinux sodium 5 MG/ML Prefilled Syringe | SCD | 49e0d7bc-3f49-849b-c77c-98682d1c0d19 | 16 |
| 861365 | 0.6 ML fondaparinux sodium 12.5 MG/ML Prefilled Syringe | SCD | 49e0d7bc-3f49-849b-c77c-98682d1c0d19 | 16 |
| 861356 | 0.8 ML fondaparinux sodium 12.5 MG/ML Prefilled Syringe | SCD | 49e0d7bc-3f49-849b-c77c-98682d1c0d19 | 16 |
| 861356 | fondaparinux sodium 10 MG per 0.8 ML Prefilled Syringe | SY | 49e0d7bc-3f49-849b-c77c-98682d1c0d19 | 16 |
| 861360 | fondaparinux sodium 2.5 MG per 0.5 ML Prefilled Syringe | SY | 49e0d7bc-3f49-849b-c77c-98682d1c0d19 | 16 |
| 861363 | fondaparinux sodium 5 MG per 0.4 ML Prefilled Syringe | SY | 49e0d7bc-3f49-849b-c77c-98682d1c0d19 | 16 |
| 861365 | fondaparinux sodium 7.5 MG per 0.6 ML Prefilled Syringe | SY | 49e0d7bc-3f49-849b-c77c-98682d1c0d19 | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55111-679-02 | 55111067902 | 2 SYRINGE in 1 CARTON (55111-679-02) / .4 mL in 1 SYRINGE (55111-679-11) | 2 syringe | 2011-07-14 | 0000-00-00 | No | No | Current |
| 55111-679-10 | 55111067910 | 10 SYRINGE in 1 CARTON (55111-679-10) / .4 mL in 1 SYRINGE (55111-679-11) | 10 syringe | 2011-07-14 | 0000-00-00 | No | No | Current |
| 55111-679-11 | 55111067911 | 0.4 mL in 1 SYRINGE | 0.4 ml | Historical |