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NDC 64980-0427-12 Tindazole 500 mg/1 Details
Tindazole 500 mg/1
Tindazole is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Rising Pharma Holdings, Inc.. The primary component is TINIDAZOLE.
MedlinePlus Drug Summary
Tinidazole is used to treat trichomoniasis (a sexually transmitted disease that can affect men and women), giardiasis (an infection of the intestine that can cause diarrhea, gas, and stomach cramps), and amebiasis (an infection of the intestine that can cause diarrhea, gas, and stomach cramps and can spread to other organs such as the liver). Tinidazole is also used to treat bacterial vaginosis (an infection caused by an overgrowth of harmful bacteria in the vagina) in women. Tinidazole is in a class of medications called nitroimidazole antimicrobials. It works by killing the organisms that can cause infection. Antibiotics will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Related Packages: 64980-0427-12Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Tinidazole
Product Information
| NDC | 64980-0427 |
|---|---|
| Product ID | 64980-427_37044541-dbe9-4d1b-b052-ddf0559f39aa |
| Associated GPIs | 16000053000320 |
| GCN Sequence Number | 019048 |
| GCN Sequence Number Description | tinidazole TABLET 500 MG ORAL |
| HIC3 | W4G |
| HIC3 Description | 2ND GEN. ANAEROBIC ANTIPROTOZOAL-ANTIBACTERIAL |
| GCN | 52220 |
| HICL Sequence Number | 007779 |
| HICL Sequence Number Description | TINIDAZOLE |
| Brand/Generic | Generic |
| Proprietary Name | Tindazole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Tinidazole |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | TINIDAZOLE |
| Labeler Name | Rising Pharma Holdings, Inc. |
| Pharmaceutical Class | Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA202489 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 64980-0427-12 (64980042712)
| NDC Package Code | 64980-427-12 |
|---|---|
| Billing NDC | 64980042712 |
| Package | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12) |
| Marketing Start Date | 2013-10-09 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 2.6988 |
| Pricing Unit | EA |
| Effective Date | 2024-01-17 |
| NDC Description | TINIDAZOLE 500 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |