Isoniazid
- Product NDC
- 63187-978
- 11-digit product format
- 631870978
- Labeler code
- 63187
- Product ID
- 63187-978_5c1e5064-9311-4161-a11f-1e006dd97bfb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isoniazid
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- 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
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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-978-30 | Isoniazid | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 63187-978-60 | Isoniazid | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
| 63187-978-90 | Isoniazid | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-978 | ISONIAZID TABLET [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 3 package rows | 20191105_65e50989-d24c-4bb3-a041-d6aea2635ef1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-978-30 | 63187097830 | 30 TABLET in 1 BOTTLE (63187-978-30) | 30 tablet | 2018-02-01 | 0000-00-00 | No | No | Current |
| 63187-978-60 | 63187097860 | 60 TABLET in 1 BOTTLE (63187-978-60) | 60 tablet | 2018-02-01 | 0000-00-00 | No | No | Current |
| 63187-978-90 | 63187097890 | 90 TABLET in 1 BOTTLE (63187-978-90) | 90 tablet | 2018-02-01 | 0000-00-00 | No | No | Current |