fondaparinux sodium
- Product NDC
- 11797-156
- 11-digit product format
- 117970156
- Labeler code
- 11797
- Product ID
- 11797-156_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
- 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
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 | 7.5 mg/.6mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X0Q6N9USOZ |
| Rxcui | 861356, 861360, 861363, 861365 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11797-156-02 | fondaparinux sodium | 0.6 mL in 1 SYRINGE | INJECTION, SOLUTION | 0.6 | | 11 |
| 11797-156-06 | fondaparinux sodium | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 11 |
| 11797-156-09 | 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 |
|---|
| 11797-156 | FONDAPARINUX SODIUM INJECTION, SOLUTION [ITALFARMACO S.P.A] | 11 | Current NDC, Legacy NDC, 3 package rows | 20210105_58789e3d-e5bc-4c2e-a527-495a252fcecd.zip |
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 |
|---|
| 11797-156-02 | 11797015602 | 0.6 mL in 1 SYRINGE | 0.6 ml | | | | | Historical |
| 11797-156-06 | 11797015606 | 10 SYRINGE in 1 CARTON (11797-156-06) / .6 mL in 1 SYRINGE (11797-156-02) | 10 syringe | 2019-02-06 | 0000-00-00 | No | No | Current |
| 11797-156-09 | 11797015609 | 2 SYRINGE in 1 CARTON (11797-156-09) / .6 mL in 1 SYRINGE (11797-156-02) | 2 syringe | 2019-02-06 | 0000-00-00 | No | No | Current |