Riastap
- Product NDC
- 63833-892
- 11-digit product format
- 638330892
- Labeler code
- 63833
- Product ID
- 63833-892_703efe5b-eb9f-4690-abb8-e446feaa702f
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- FIBRINOGEN HUMAN
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- CSL Behring GmbH
- Application
- BLA125317
- Marketing category
- BLA
- Marketing start
- 2009-01-16
- Substance
- FIBRINOGEN HUMAN
- Active strength
- 2600 mg/100mL
- Pharmacologic classes
- Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Riastap
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FIBRINOGEN HUMAN | 2600 mg/100mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63833-892-51 | Riastap | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 19 |
| 63833-892-90 | Riastap | 100 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 100 | | 19 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Fibrinogen Human | ACTIVE INGREDIENT | N94833051K | RIASTAP (FIBRINOGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CSL BEHRING GMBH] | 10 | |
| Fibrinogen Human | ACTIVE MOIETY | N94833051K | RIASTAP (FIBRINOGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CSL BEHRING GMBH] | 10 | |
| Albumin Human | INACTIVE INGREDIENT | ZIF514RVZR | RIASTAP (FIBRINOGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CSL BEHRING GMBH] | 10 | |
| arginine hydrochloride | INACTIVE INGREDIENT | F7LTH1E20Y | RIASTAP (FIBRINOGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CSL BEHRING GMBH] | 10 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | RIASTAP (FIBRINOGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CSL BEHRING GMBH] | 10 | |
| Sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | RIASTAP (FIBRINOGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CSL BEHRING GMBH] | 10 | |
| Sodium citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | RIASTAP (FIBRINOGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CSL BEHRING GMBH] | 10 | |
| Sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | RIASTAP (FIBRINOGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CSL BEHRING GMBH] | 10 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | RIASTAP (FIBRINOGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CSL BEHRING GMBH] | 10 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 63833-892-51 | 63833089251 | 1 VIAL, GLASS in 1 CARTON (63833-892-51) / 100 mL in 1 VIAL, GLASS (63833-892-90) | | 2009-01-16 | No | No | Current |
| 63833-892-90 | 63833089290 | 100 mL in 1 VIAL, GLASS | 100 ml | | | | Historical |