Quick answers
- What is Isoniazid used for?
- The FDA-approved label (Isoniazid, Remedyrepack Inc., September 4, 2026) says: “Isoniazid tablets, USP are recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid or any other medication, is inadequate therapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Isoniazid have a boxed warning?
- Yes. The FDA label for Isoniazid has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Isoniazid?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Isoniazid been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Isoniazid?
- 14 companies list prescription products of Isoniazid in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Omnivium Pharmaceuticals LLC..
What Isoniazid is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Isoniazid tablets, USP are recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with isoniazid or any other medication, is inadequate therapy. …
— FDA label: Isoniazid, Remedyrepack Inc., effective September 4, 2026. Read the full label on DailyMed →
The FDA has 23 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
23 of 23 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Solution · Injection, solution |
|---|---|
| Route | Oral · Intramuscular |
| Prescription products | 27 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| isoniazid 100 mg tablet | Generic | $1.73 per tablet |
| isoniazid 300 mg tablet | Generic | $3.32 per tablet |
NADAC list of November 4, 2026; these prices took effect between June 17, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack5 products
- A-S Medication Solutions3 products
- Omnivium Pharmaceuticals LLC.2 products
- Chartwell RX, LLC2 products
- Coupler LLC2 products
- Teva Pharmaceuticals USA, Inc.2 products
- Marlex Pharmaceuticals, Inc.2 products
- Genus Lifesciences2 products
- Remedyrepack Inc.2 products
- Aphena Pharma Solutions - Tennessee, LLC1 product
- Sandoz Inc1 product
- CMP Pharma, Inc.1 product
- Proficient Rx LP1 product
- Mylan Institutional Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (7)
- ANDA080936Genus Lifesciences · August 24, 1972
- ANDA080937Genus Lifesciences · August 24, 1972
- ANDA088235Cmp Pharma Inc · November 10, 1983
- ANDA089776Chartwell Molecular · June 13, 1988
- ANDA040090Omnivium Pharms · June 26, 1997
- ANDA081118Chartwell Rx · July 21, 1997
- ANDA040648Sandoz · July 5, 2005
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 105292, 197832, 204430, 311166 |
|---|---|
| SPL set ID of the quoted label | 6dab7b7b-a3a9-47ef-b423-134bc6970d8b |
| FDA labels (SPL) | 23 |
| FDA applications | 7 ANDA |
| Active ingredients (FDA) | ISONIAZID |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Isoniazid, Remedyrepack Inc., effective September 4, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →