Medicine
Isoniazid 300 mg tablet
Isoniazid 300 mg tablet is a generic prescription medicine for oral use, made by 12 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Isoniazid
- Brand
- Sold under the generic name
- Strength
- 300 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 90 tablets, 30 tablets, 100 tablets and 30 more
- Manufacturers
- Bryant Ranch PrepackRemedyrepackA-S Medication SolutionsOmnivium PharmaceuticalsProficient RxCouplerGenus LifesciencesMarlex PharmaceuticalsTeva PharmaceuticalsAphena Pharma Solutions - Tennessee
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J04AC01 Isoniazid
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 September 1972
- Identifiers
- RxCUI 197832, 311166DailyMed set ID 9dbaacc4-ed2a-4a9b-83a9-c001d3d9f71c, 35400f1d-fd25-4bfa-a382-ac390e21bf2e, 6dab7b7b-a3a9-47ef-b423-134bc6970d8b +14NDC 71335-2760, 81665-108, 70518-4315 +14Application ANDA080937, ANDA040090, ANDA089776
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 90 tablet in 1 bottle | 62135-709-90 | Chartwell RX | 20 October 2023 |
| 30 tablet in 1 bottle | 64950-217-03 | Genus Lifesciences | 1 November 2024 |
| 100 tablet in 1 bottle | 64950-217-10 | Genus Lifesciences | 1 November 2024 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 51079-083-20 | Mylan Institutional | 9 June 1994 |
| 100 tablet in 1 bottle, plastic | 81665-108-10 | Omnivium Pharmaceuticals | 15 October 2024 |
| 30 tablet in 1 bottle, plastic | 81665-108-30 | Omnivium Pharmaceuticals | 15 October 2024 |
| 1000 tablet in 1 bottle, plastic | 81665-108-51 | Omnivium Pharmaceuticals | 15 October 2024 |
| 30 tablet in 1 bottle, unit-dose | 0555-0071-01 | Teva Pharmaceuticals | 1 September 1972 |
| 100 tablet in 1 bottle | 0555-0071-02 | Teva Pharmaceuticals | 1 September 1972 |
| 30 tablet in 1 bottle | 71335-2760-1 | Bryant Ranch Prepack | 1 November 2024 |
| 100 tablet in 1 bottle | 71335-2800-1 | Bryant Ranch Prepack | 13 October 2025 |
| 30 tablet in 1 bottle | 71335-2800-2 | Bryant Ranch Prepack | 13 October 2025 |
| 60 tablet in 1 bottle | 71335-2800-3 | Bryant Ranch Prepack | 13 October 2025 |
| 35 tablet in 1 bottle | 71335-2800-4 | Bryant Ranch Prepack | 13 October 2025 |
| 90 tablet in 1 bottle | 71335-2800-5 | Bryant Ranch Prepack | 13 October 2025 |
| 100 tablet in 1 bottle | 72162-2445-1 | Bryant Ranch Prepack | 12 February 2025 |
| 30 tablet in 1 bottle | 72162-2445-3 | Bryant Ranch Prepack | 12 February 2025 |
| 50 tablet in 1 bottle | 50090-0370-0 | A-S Medication Solutions | 23 October 2018 |
| 30 tablet in 1 bottle | 50090-0370-3 | A-S Medication Solutions | 29 June 2016 |
| 30 tablet in 1 bottle | 50090-7660-3 | A-S Medication Solutions | 29 September 2025 |
| 30 tablet in 1 blister pack | 67046-1570-3 | Coupler | 2 July 2025 |
| 30 tablet in 1 blister pack | 67046-1617-3 | Coupler | 24 November 2025 |
| 30 tablet in 1 blister pack | 70518-4315-0 | Remedyrepack | 20 March 2025 |
| 30 tablet in 1 bottle, plastic | 70518-4315-1 | Remedyrepack | 1 May 2025 |
| 45 tablet in 1 bottle, plastic | 70518-4315-2 | Remedyrepack | 12 May 2025 |
| 12 tablet in 1 bottle, plastic | 70518-4540-0 | Remedyrepack | 23 December 2025 |
| 30 tablet in 1 blister pack | 70518-4540-1 | Remedyrepack | 21 January 2026 |
| 30 tablet in 1 bottle, plastic | 71610-395-30 | Aphena Pharma Solutions - Tennessee | 21 February 2020 |
| 100 tablet in 1 bottle, plastic | 10135-805-01 | Marlex Pharmaceuticals | 1 March 2025 |
| 30 tablet in 1 bottle, plastic | 10135-805-30 | Marlex Pharmaceuticals | 1 March 2025 |
| 30 tablet in 1 bottle | 63187-978-30 | Proficient Rx | 1 February 2018 |
| 60 tablet in 1 bottle | 63187-978-60 | Proficient Rx | 1 February 2018 |
| 90 tablet in 1 bottle | 63187-978-90 | Proficient Rx | 1 February 2018 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 29 September 1952 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Isoniazid
Clinical summary
Isoniazid is an antimycobacterial. It is available as tablets, oral solution and injection for intramuscular use. MedsAcross supplies Isoniazid for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about IsoniazidFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Isoniazid prescribing information (Chartwell RX) · U.S. National Library of Medicine, DailyMed
Need Isoniazid 300 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.