Terbinafine Hydrochloride
- Product NDC
- 64679-209
- 11-digit product format
- 646790209
- Labeler code
- 64679
- Product ID
- 64679-209_0fe68d55-9607-4271-95de-395b13eabeb4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbinafine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Wockhardt USA, LLC
- Application
- ANDA077533
- Marketing category
- ANDA
- Marketing start
- 2008-01-04
- Marketing end
- 0000-00-00
- Substance
- TERBINAFINE HYDROCHLORIDE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Allylamine [CS],Allylamine Antifungal [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Terbinafine Hydrochloride | ACTIVE INGREDIENT | 012C11ZU6G | TERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT USA, LLC] | 1 | |
| Terbinafine | ACTIVE MOIETY | G7RIW8S0XP | TERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT USA, LLC] | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | TERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT USA, LLC] | 1 | |
| hypromellose | INACTIVE INGREDIENT | 3NXW29V3WO | TERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT USA, LLC] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | TERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT USA, LLC] | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT USA, LLC] | 1 | |
| sodium starch glycolate type a potato | INACTIVE INGREDIENT | 5856J3G2A2 | TERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT USA, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64679-209 | TERBINAFINE HYDROCHLORIDE TABLET [WOCKHARDT USA, LLC] | 1 | Legacy NDC | 20091217_f1950185-b677-42f6-a68e-d2b9e7c55e91.zip |