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NDC 00310-3200-04 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 AstraZeneca Pharmaceuticals LP. The primary component is ANDEXANET ALFA.
Product Information
NDC | 00310-3200 |
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Product ID | 0310-3200_b603803b-80eb-4097-aa98-3bd692bce171 |
Associated GPIs | |
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 | AstraZeneca Pharmaceuticals LP |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA125586 |
Listing Certified Through | 2024-12-31 |
Package
NDC 00310-3200-04 (00310320004)
NDC Package Code | 0310-3200-04 |
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Billing NDC | 00310320004 |
Package | 4 VIAL, SINGLE-USE in 1 CARTON (0310-3200-04) / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01) |
Marketing Start Date | 2022-07-12 |
NDC Exclude Flag | N |
Pricing Information | N/A |