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NDC 61919-0032-14 METRONIDAZOLE 500 mg/1 Details
METRONIDAZOLE 500 mg/1
METRONIDAZOLE is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by DIRECT RX. The primary component is METRONIDAZOLE.
MedlinePlus Drug Summary
Metronidazole capsules and tablets are used to treat infections of the reproductive system, gastrointestinal (GI) tract, skin, heart, bone, joint, lung, blood, nervous system, and other areas of the body. Metronidazole capsules and tablets are also used to treat sexually transmitted diseases (STDs). Metronidazole extended-release (long-acting) tablets are used to treat bacterial vaginosis (an infection caused by too much of certain types of harmful bacteria in the vagina) in women. Metronidazole is in a class of medications called nitroimidazole antimicrobials. It works by stopping the growth of bacteria. 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: 61919-0032-14Last Updated: 02/05/2023
MedLinePlus Full Drug Details: Metronidazole
Product Information
| NDC | 61919-0032 |
|---|---|
| Product ID | 61919-032_0e87acda-b95f-eefa-e063-6394a90abb00 |
| Associated GPIs | 16000035000310 |
| GCN Sequence Number | 009592 |
| GCN Sequence Number Description | metronidazole TABLET 500 MG ORAL |
| HIC3 | W4E |
| HIC3 Description | ANAEROBIC ANTIPROTOZOAL-ANTIBACTERIAL AGENTS |
| GCN | 43032 |
| HICL Sequence Number | 004157 |
| HICL Sequence Number Description | METRONIDAZOLE |
| Brand/Generic | Generic |
| Proprietary Name | METRONIDAZOLE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | METRONIDAZOLE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | METRONIDAZOLE |
| Labeler Name | DIRECT RX |
| Pharmaceutical Class | Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA203458 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 61919-0032-14 (61919003214)
| NDC Package Code | 61919-032-14 |
|---|---|
| Billing NDC | 61919003214 |
| Package | 14 TABLET, FILM COATED in 1 BOTTLE (61919-032-14) |
| Marketing Start Date | 2017-02-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |