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NDC 62135-0550-47 Isoniazid 50 mg/5mL Details
Isoniazid 50 mg/5mL
Isoniazid is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Chartwell RX, LLC. The primary component is ISONIAZID.
MedlinePlus Drug Summary
Isoniazid is used with other drugs to treat tuberculosis (TB; a serious infection that affects the lungs and sometimes other parts of the body). Isoniazid is also used with other drugs to treat people with latent (resting or nongrowing) TB including those in close contact with people who have active TB, a positive tuberculin skin test, human immunodeficiency virus (HIV), and those with pulmonary fibrosis (scarring of the lungs with an unknown cause). Isoniazid is in a class of medications called antituberculosis agents. It works by killing the bacteria that cause tuberculosis.
Related Packages: 62135-0550-47Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Isoniazid
Product Information
| NDC | 62135-0550 |
|---|---|
| Product ID | 62135-550_fbea0b55-586d-b7ea-e053-6394a90acb9a |
| Associated GPIs | |
| GCN Sequence Number | 009414 |
| GCN Sequence Number Description | isoniazid SOLUTION 50 MG/5 ML ORAL |
| HIC3 | W2E |
| HIC3 Description | ANTI-MYCOBACTERIUM AGENTS |
| GCN | 41730 |
| HICL Sequence Number | 004080 |
| HICL Sequence Number Description | ISONIAZID |
| Brand/Generic | Generic |
| Proprietary Name | Isoniazid |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Isoniazid |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/5mL |
| Substance Name | ISONIAZID |
| Labeler Name | Chartwell RX, LLC |
| Pharmaceutical Class | Antimycobacterial [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA081118 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 62135-0550-47 (62135055047)
| NDC Package Code | 62135-550-47 |
|---|---|
| Billing NDC | 62135055047 |
| Package | 473 mL in 1 BOTTLE (62135-550-47) |
| Marketing Start Date | 2023-05-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |