isoniazid
- Product NDC
- 10135-805
- 11-digit product format
- 101350805
- Labeler code
- 10135
- Product ID
- 10135-805_3e871908-abb7-9d35-e063-6394a90ac63d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isoniazid
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals, Inc.
- Application
- ANDA040090
- Marketing category
- ANDA
- Marketing start
- 2025-03-01
- 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 |
|---|
| 10135-805-01 | 10135080501 | 100 TABLET in 1 BOTTLE, PLASTIC (10135-805-01) | 100 tablet | 2025-03-01 | No | No | Historical |
| 10135-805-30 | 10135080530 | 30 TABLET in 1 BOTTLE, PLASTIC (10135-805-30) | 30 tablet | 2025-03-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Isoniazid Tablets | Marlex Pharmaceuticals, Inc. | 2025-09-11 | HUMAN PRESCRIPTION DRUG LABEL | 3 |