Profilnine
- Product NDC
- 68516-3210
- 11-digit product format
- 685163210
- Labeler code
- 68516
- Product ID
- 68516-3210_d13b6d66-7106-4a34-8521-1cf16d2578b9
- 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
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Profilnine
- Listing expiration
- 2027-12-31
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68516-3204-1 | Profilnine | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 mL | 500 [iU] in 5mL | 33 |
| 68516-3210-1 | Profilnine | 1 in 1 CARTON | KIT | 1 | | 33 |
| 76297-002-02 | Profilnine | 5 mL in 1 VIAL, GLASS | SOLUTION | 5 mL | 1 mL in 1mL | 33 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68516-3210 | PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC] | 29 | Current NDC, 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 |
|---|
| 68516-3204-1 | 68516320401 | 5 mL in 1 VIAL | 5 ml | | | | | Historical |
| 68516-3210-1 | 68516321001 | 1 KIT in 1 CARTON (68516-3210-1) * 5 mL in 1 VIAL (68516-3204-1) * 5 mL in 1 VIAL, GLASS (76297-002-02) | 1 kit | 1981-07-20 | 0000-00-00 | No | No | Current |
| 76297-002-02 | 76297000202 | 5 mL in 1 VIAL, GLASS | 5 ml | | | | | Historical |