isoniazid
- Product NDC
- 81665-107
- 11-digit product format
- 816650107
- Labeler code
- 81665
- Product ID
- 81665-107_3966e8ed-31f4-6d0a-e063-6294a90a3233
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isoniazid
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- OMNIVIUM PHARMACEUTICALS LLC.
- Application
- ANDA040090
- Marketing category
- ANDA
- Marketing start
- 2024-10-15
- Substance
- ISONIAZID
- Active strength
- 100 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 | 100 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 |
|---|
| 81665-107-10 | isoniazid | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81665-107 | ISONIAZID TABLET [OMNIVIUM PHARMACEUTICALS LLC.] | 1 | Current NDC, 1 package rows | 20241022_35400f1d-fd25-4bfa-a382-ac390e21bf2e.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 |
|---|
| 81665-107-10 | 81665010710 | 100 TABLET in 1 BOTTLE, PLASTIC (81665-107-10) | 100 tablet | 2024-10-15 | No | No | Historical |