Octaplas
- Product NDC
- 68982-953
- 11-digit product format
- 689820953
- Labeler code
- 68982
- Product ID
- 68982-953_40d9021f-46b6-7a20-e260-1c6ea020e1ae
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- human plasma proteins
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Octapharma USA Inc
- Application
- BLA125416
- Marketing category
- BLA
- Marketing start
- 2013-07-18
- Substance
- PLASMA PROTEIN FRACTION (HUMAN)
- Active strength
- 11.5 g/200mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Octaplas
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PLASMA PROTEIN FRACTION (HUMAN) | 11.5 g/200mL |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68982-953-01 | Octaplas | 200 mL in 1 BAG | SOLUTION | 200 | | 25 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68982-953 | OCTAPLAS (HUMAN PLASMA PROTEINS) SOLUTION [OCTAPHARMA USA INC] | 25 | Current NDC, Legacy NDC, 1 package rows | 20241004_b4981410-de8e-8401-a720-f6df2561fbc1.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68982-953-01 | 68982095301 | 200 mL in 1 BAG (68982-953-01) | 200 ml | 2013-07-18 | 0000-00-00 | No | No | Current |