Ixinity
- Product NDC
- 59137-289
- 11-digit product format
- 591370289
- Labeler code
- 59137
- Product ID
- 59137-289_5e2b1242-2977-463b-ac2c-f89dadfba407
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- coagulation factor IX (recombinant)
- Dosage form
- KIT
- Labeler
- Medexus Pharma, Inc.
- Application
- BLA125426
- Marketing category
- BLA
- Marketing start
- 2017-05-12
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ixinity
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 1666311, 1666328 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59137-277-01 | Ixinity | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 3000 [iU] in 5mL | 8 |
| 59137-289-05 | Ixinity | 1 in 1 CARTON | KIT | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59137-289 | IXINITY (COAGULATION FACTOR IX (RECOMBINANT)) KIT [MEDEXUS PHARMA, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240405_26bc221d-c9bc-4aba-92f3-6c21acaaf194.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 |
|---|
| 59137-277-01 | 59137027701 | 5 mL in 1 VIAL | 5 ml | | | | | Historical |
| 59137-289-05 | 59137028905 | 1 KIT in 1 CARTON (59137-289-05) * 5 mL in 1 VIAL (59137-277-01) * 5 mL in 1 SYRINGE (59137-280-01) | 1 kit | 2021-07-01 | 0000-00-00 | No | No | Current |