Isoniazid
- Product NDC
- 62135-550
- 11-digit product format
- 621350550
- Labeler code
- 62135
- Product ID
- 62135-550_44fdc5f6-d8fc-49a1-e063-6394a90ad33c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isoniazid
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA081118
- Marketing category
- ANDA
- Marketing start
- 1997-07-21
- Substance
- ISONIAZID
- Active strength
- 50 mg/5mL
- 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 | 50 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V83O1VOZ8L |
| Rxcui | 105292 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-550-47 | Isoniazid | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-550 | ISONIAZID SOLUTION [CHARTWELL RX, LLC] | 1 | Current NDC, 1 package rows | 20230520_8a6fa0b2-48e3-4c06-97c5-9ec3d6475a7c.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 |
|---|
| 62135-550-47 | 62135055047 | 473 mL in 1 BOTTLE (62135-550-47) | 473 ml | 2023-05-10 | No | No | Current |