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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- isoniazid
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISONIAZID | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V83O1VOZ8L |
| Rxcui | 197832, 311166 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-805-01 | isoniazid | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 3 |
| 10135-805-30 | isoniazid | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-805 | ISONIAZID TABLET [MARLEX PHARMACEUTICALS, INC.] | 2 | Current NDC, 2 package rows | 20250406_312cd403-b211-64ef-e063-6394a90aab88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |
| 10135-805-30 | 10135080530 | 30 TABLET in 1 BOTTLE, PLASTIC (10135-805-30) | 30 tablet | 2025-03-01 | No | No | Current |