Isoniazid
- Product NDC
- 71610-395
- 11-digit product format
- 716100395
- Labeler code
- 71610
- Product ID
- 71610-395_10b9b8c8-0cfc-47b7-9324-bbd6f2617b5f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isoniazid
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA080937
- Marketing category
- ANDA
- Marketing start
- 1972-09-01
- Substance
- ISONIAZID
- Active strength
- 300 mg/1
- Pharmacologic classes
- Antimycobacterial [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| V83O1VOZ8L | ISONIAZID | 54-85-3 | ISONIAZID |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-395-30 | 71610039530 | 30 TABLET in 1 BOTTLE, PLASTIC (71610-395-30) | 30 tablet | 2020-02-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Isoniazid Tablets USP | Aphena Pharma Solutions - Tennessee, LLC | 2020-03-23 | HUMAN PRESCRIPTION DRUG LABEL | 1 |