REBINYN
- Product NDC
- 0169-7905
- 11-digit product format
- 001697905
- Labeler code
- 0169
- Product ID
- 0169-7905_4d658384-07d9-471f-8b15-16b8cec36765
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- coagulation factor IX recombinant, GlycoPEGylated
- Dosage form
- KIT
- Labeler
- Novo Nordisk
- Application
- BLA125611
- Marketing category
- BLA
- Marketing start
- 2017-12-01
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- REBINYN
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 1990857, 1990862 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0169-7905-01 | REBINYN | 1 in 1 KIT | KIT | 1 | | 9 |
| 0169-7905-97 | REBINYN | 1 in 1 KIT | KIT | 1 | | 9 |
| 0169-7955-11 | REBINYN | 4 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 4 mL | 125 [iU] in 1mL | 9 |
| 0169-7955-90 | REBINYN | 4 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 4 mL | 125 [iU] in 1mL | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0169-7905 | REBINYN (COAGULATION FACTOR IX RECOMBINANT, GLYCOPEGYLATED) KIT [NOVO NORDISK] | 9 | Current NDC, Legacy NDC, 4 package rows | 20240808_0ea37235-35fd-410d-b8c4-40ba15fe1294.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 |
|---|
| 0169-7905-01 | 00169790501 | 1 KIT in 1 KIT (0169-7905-01) * 4 mL in 1 VIAL, GLASS (0169-7955-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7955-11) | 1 kit | 2017-12-01 | 0000-00-00 | No | No | Current |
| 0169-7905-97 | 00169790597 | 1 KIT in 1 KIT (0169-7905-97) * 4 mL in 1 VIAL, GLASS (0169-7955-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7955-11) | 1 kit | 2022-05-05 | 0000-00-00 | Yes | No | Current |
| 0169-7955-11 | 00169795511 | 4 mL in 1 VIAL, GLASS | 4 ml | | | | | Historical |
| 0169-7955-90 | 00169795590 | 4 mL in 1 VIAL, GLASS | 4 ml | | | | | Historical |