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NDC 39822-1000-01 Tranexamic Acid 100 mg/mL Details
Tranexamic Acid 100 mg/mL
Tranexamic Acid is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by XGen Pharmaceuticals DJB, Inc.. The primary component is TRANEXAMIC ACID.
Product Information
| NDC | 39822-1000 |
|---|---|
| Product ID | 39822-1000_fd8f9b33-2451-7a8c-e053-6294a90a7b52 |
| Associated GPIs | 84100040002025 |
| GCN Sequence Number | 068183 |
| GCN Sequence Number Description | tranexamic acid VIAL 1000 MG/10 INTRAVEN |
| HIC3 | M9D |
| HIC3 Description | ANTIFIBRINOLYTIC AGENTS |
| GCN | 30912 |
| HICL Sequence Number | 002802 |
| HICL Sequence Number Description | TRANEXAMIC ACID |
| Brand/Generic | Generic |
| Proprietary Name | Tranexamic Acid |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Tranexamic Acid |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/mL |
| Substance Name | TRANEXAMIC ACID |
| Labeler Name | XGen Pharmaceuticals DJB, Inc. |
| Pharmaceutical Class | Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA201580 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 39822-1000-01 (39822100001)
| NDC Package Code | 39822-1000-1 |
|---|---|
| Billing NDC | 39822100001 |
| Package | 10 VIAL in 1 CARTON (39822-1000-1) / 10 mL in 1 VIAL |
| Marketing Start Date | 2012-05-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |