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NDC 69853-0102-01 ANDEXXA 200 mg/20mL Details
ANDEXXA 200 mg/20mL
ANDEXXA is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Alexion Pharmaceuticals, Inc.. The primary component is ANDEXANET ALFA.
Product Information
| NDC | 69853-0102 |
|---|---|
| Product ID | 69853-0102_cbcf849a-3069-4f9c-af6b-54364b3172d6 |
| Associated GPIs | 93000014402130 |
| GCN Sequence Number | 079424 |
| GCN Sequence Number Description | factor Xa,inactivated-zhzo VIAL 200 MG INTRAVEN |
| HIC3 | M9Y |
| HIC3 Description | ANTICOAGULANT REVERSAL AGENT FOR FACTOR XA INHIB. |
| GCN | 45915 |
| HICL Sequence Number | 044899 |
| HICL Sequence Number Description | COAGULATION FACTOR XA,INACTIVATED-ZHZO (RECOMBINANT) |
| Brand/Generic | Brand |
| Proprietary Name | ANDEXXA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | andexanet alfa |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/20mL |
| Substance Name | ANDEXANET ALFA |
| Labeler Name | Alexion Pharmaceuticals, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125586 |
| Listing Certified Through | n/a |
Package
NDC 69853-0102-01 (69853010201)
| NDC Package Code | 69853-0102-1 |
|---|---|
| Billing NDC | 69853010201 |
| Package | 4 VIAL, SINGLE-USE in 1 CARTON (69853-0102-1) / 20 mL in 1 VIAL, SINGLE-USE |
| Marketing Start Date | 2019-01-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |