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NDC 43066-0008-10 TRANEXAMIC ACID 100 mg/mL Details
TRANEXAMIC ACID 100 mg/mL
TRANEXAMIC ACID is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is TRANEXAMIC ACID.
Product Information
| NDC | 43066-0008 |
|---|---|
| Product ID | 43066-008_d16fa2b3-f9ba-4d64-b7b2-19f2a1a39ef3 |
| 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 |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/mL |
| Substance Name | TRANEXAMIC ACID |
| Labeler Name | Baxter Healthcare Corporation |
| Pharmaceutical Class | Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA212360 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43066-0008-10 (43066000810)
| NDC Package Code | 43066-008-10 |
|---|---|
| Billing NDC | 43066000810 |
| Package | 10 CARTON in 1 BOX (43066-008-10) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (43066-008-01) |
| Marketing Start Date | 2020-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |