Ethambutol Hydrochloride
- Product NDC
- 68850-005
- 11-digit product format
- 688500005
- Labeler code
- 68850
- Product ID
- 68850-005_f8939d3c-f0f7-4fb3-baf6-6b150c426f50
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ethambutol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- STI Pharma
- Application
- NDA016320
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2006-12-15
- Marketing end
- 0000-00-00
- Substance
- ETHAMBUTOL HYDROCHLORIDE
- Active strength
- 400 mg/1
- Pharmacologic classes
- Antimycobacterial [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68850-005-01 | Ethambutol Hydrochloride | 12 in 1 CARTON | TABLET, FILM COATED | 12 | | 2 |
| 68850-005-01 | Ethambutol Hydrochloride | 12 in 1 BOX | TABLET, FILM COATED | 12 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Ethambutol Hydrochloride | ACTIVE INGREDIENT | QE4VW5FO07 | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA] | 2 | |
| Ethambutol | ACTIVE MOIETY | 8G167061QZ | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA] | 2 | |
| Gelatin | INACTIVE INGREDIENT | 2G86QN327L | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA] | 2 | |
| Hydroxypropyl cellulose | INACTIVE INGREDIENT | RFW2ET671P | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA] | 2 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA] | 2 | |
| Sodium Lauryl Sulfate | INACTIVE INGREDIENT | 368GB5141J | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA] | 2 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA] | 2 | |
| Stearic Acid | INACTIVE INGREDIENT | 4ELV7Z65AP | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA] | 2 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA] | 2 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68850-005 | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA] | 2 | Legacy NDC, 2 package rows | 20120817_d123fbd1-57de-47c6-963f-54d69427290b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 68850-005-01 | 68850000501 | 12 in 1 CARTON | Historical |