ETHAMBUTOL HYDROCHLORIDE
- Product NDC
- 10135-797
- 11-digit product format
- 101350797
- Labeler code
- 10135
- Product ID
- 10135-797_2dcb6b41-b9a8-4dde-8248-334d13f87a29
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ETHAMBUTOL HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals, Inc.
- Application
- NDA016320
- Marketing category
- NDA
- Marketing start
- 2006-12-15
- Substance
- ETHAMBUTOL HYDROCHLORIDE
- Active strength
- 400 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
- ETHAMBUTOL HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETHAMBUTOL HYDROCHLORIDE | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QE4VW5FO07 |
| Rxcui | 995599, 995607 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-797-01 | ETHAMBUTOL HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 10135-797-01 | 10135079701 | 100 TABLET, FILM COATED in 1 BOTTLE (10135-797-01) | 2025-08-26 | No | No | Current |