Profilnine
- Product NDC
- 68516-3209
- 11-digit product format
- 685163209
- Labeler code
- 68516
- Product ID
- 68516-3209_c1e84e75-ad02-456e-ad85-fe92d659e7e1
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- factor ix complex
- Dosage form
- KIT
- Route
- INTRAVENOUS
- Labeler
- GRIFOLS USA, LLC
- Application
- BLA102476
- Marketing category
- BLA
- Marketing start
- 1981-07-20
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68516-1002-2 | Profilnine | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 mL | 1 mL in 1mL | 33 |
| 68516-3206-2 | Profilnine | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 mL | 1500 [iU] in 10mL | 33 |
| 68516-3209-2 | Profilnine | 1 in 1 CARTON | KIT | 1 | | 33 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68516-3209 | PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] | 29 | Legacy NDC, 3 package rows | 20230830_79821042-86a5-4a64-b621-76de0a0bbab2.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 |
|---|
| 68516-1002-2 | 68516100202 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | | Historical |
| 68516-3206-2 | 68516320602 | 10 mL in 1 VIAL | 10 ml | | | | | Historical |
| 68516-3209-2 | 68516320902 | 1 KIT in 1 CARTON (68516-3209-2) * 10 mL in 1 VIAL (68516-3206-2) * 10 mL in 1 VIAL, SINGLE-DOSE (68516-1002-2) | 1 kit | 1981-07-20 | 0000-00-00 | No | No | Current |