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NDC 00642-7463-12 Benznidazole 12.5 mg/1 Details
Benznidazole 12.5 mg/1
Benznidazole is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Exeltis USA, Inc.. The primary component is BENZNIDAZOLE.
MedlinePlus Drug Summary
Benznidazole is used to treat Chagas disease (caused by a parasite) in children 2 to 12 years old. Benznidazole is in a class of medications called antiprotozoals. It works by killing the organism that can cause Chagas disease.
Related Packages: 00642-7463-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Benznidazole
Product Information
| NDC | 00642-7463 |
|---|---|
| Product ID | 0642-7463_09d1317f-8e95-b708-e063-6394a90a1ef5 |
| Associated GPIs | 15000003000320 |
| GCN Sequence Number | 077693 |
| GCN Sequence Number Description | benznidazole TABLET 12.5 MG ORAL |
| HIC3 | W4K |
| HIC3 Description | ANTIPROTOZOAL DRUGS,MISCELLANEOUS |
| GCN | 43796 |
| HICL Sequence Number | 021759 |
| HICL Sequence Number Description | BENZNIDAZOLE |
| Brand/Generic | Generic |
| Proprietary Name | Benznidazole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | benznidazole |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 12.5 |
| Active Ingredient Units | mg/1 |
| Substance Name | BENZNIDAZOLE |
| Labeler Name | Exeltis USA, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA209570 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00642-7463-12 (00642746312)
| NDC Package Code | 0642-7463-12 |
|---|---|
| Billing NDC | 00642746312 |
| Package | 1 BOTTLE in 1 CARTON (0642-7463-12) / 100 TABLET in 1 BOTTLE |
| Marketing Start Date | 2018-03-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |