isoniazid
- Product NDC
- 70518-4540
- 11-digit product format
- 705184540
- Labeler code
- 70518
- Product ID
- 70518-4540_5070b8f5-b2f4-8d89-e063-6294a90adf72
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isoniazid
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA040090
- Marketing category
- ANDA
- Marketing start
- 2025-12-23
- Substance
- ISONIAZID
- Active strength
- 300 mg/1
- Pharmacologic classes
- Antimycobacterial [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- isoniazid
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISONIAZID | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V83O1VOZ8L |
| Rxcui | 197832 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4540-0 | isoniazid | 12 in 1 BOTTLE, PLASTIC | TABLET | 12 | | 4 |
| 70518-4540-1 | isoniazid | 30 in 1 BLISTER PACK | TABLET | 30 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4540-0 | 70518454000 | 12 TABLET in 1 BOTTLE, PLASTIC (70518-4540-0) | 12 tablet | 2025-12-23 | No | No | Current |
| 70518-4540-1 | 70518454001 | 30 TABLET in 1 BLISTER PACK (70518-4540-1) | 30 tablet | 2026-01-21 | No | No | Current |