Ethambutol Hydrochloride
- Product NDC
- 54879-002
- 11-digit product format
- 548790002
- Labeler code
- 54879
- Product ID
- 54879-002_5115f4a9-63ad-ebc3-e063-6294a90a7ba8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ethambutol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- STI Pharma LLC
- Application
- NDA016320
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2006-12-15
- Substance
- ETHAMBUTOL HYDROCHLORIDE
- Active strength
- 400 mg/1
- Pharmacologic classes
- Antimycobacterial [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ethambutol Hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 54879-002-01 | Ethambutol Hydrochloride | 12 in 1 CARTON | TABLET, FILM COATED | 12 | | 9 |
| 54879-002-01 | Ethambutol Hydrochloride | 12 in 1 BOX | TABLET, FILM COATED | 12 | | 9 |
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 LLC] | 1 | |
| Ethambutol | ACTIVE MOIETY | 8G167061QZ | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC] | 1 | |
| Gelatin | INACTIVE INGREDIENT | 2G86QN327L | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC] | 1 | |
| Hydroxypropyl cellulose | INACTIVE INGREDIENT | RFW2ET671P | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC] | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC] | 1 | |
| Sodium Lauryl Sulfate | INACTIVE INGREDIENT | 368GB5141J | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC] | 1 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC] | 1 | |
| Stearic Acid | INACTIVE INGREDIENT | 4ELV7Z65AP | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC] | 1 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC] | 1 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54879-002 | ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240113_3f6428d6-3745-4337-ad78-ebfff9f49135.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 |
|---|
| 54879-002-01 | 54879000201 | 12 CARTON in 1 BOX (54879-002-01) > 12 BOTTLE in 1 CARTON > 100 TABLET, FILM COATED in 1 BOTTLE | 12 carton | 2006-12-15 | 0000-00-00 | No | No | Current |