Terbinafine Hydrochloride
- Product NDC
- 67405-500
- 11-digit product format
- 674050500
- Labeler code
- 67405
- Product ID
- 67405-500_515e977b-373d-412f-a7d2-4210197758a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbinafine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Harris Pharmaceutical, Inc.
- Application
- ANDA077137
- Marketing category
- ANDA
- Marketing start
- 2014-08-13
- Marketing end
- 0000-00-00
- Substance
- TERBINAFINE HYDROCHLORIDE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Allylamine [CS],Allylamine Antifungal [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
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 [HARRIS PHARMACEUTICAL, INC.] | 1 | |
| TERBINAFINE | ACTIVE MOIETY | G7RIW8S0XP | TERBINAFINE HYDROCHLORIDE TABLET [HARRIS PHARMACEUTICAL, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TERBINAFINE HYDROCHLORIDE TABLET [HARRIS PHARMACEUTICAL, INC.] | 1 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | TERBINAFINE HYDROCHLORIDE TABLET [HARRIS PHARMACEUTICAL, INC.] | 1 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | TERBINAFINE HYDROCHLORIDE TABLET [HARRIS PHARMACEUTICAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TERBINAFINE HYDROCHLORIDE TABLET [HARRIS PHARMACEUTICAL, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TERBINAFINE HYDROCHLORIDE TABLET [HARRIS PHARMACEUTICAL, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TERBINAFINE HYDROCHLORIDE TABLET [HARRIS PHARMACEUTICAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67405-500 | TERBINAFINE HYDROCHLORIDE TABLET [HARRIS PHARMACEUTICAL, INC.] | 3 | Legacy NDC | 20190913_caf80893-b509-408e-8824-d911c5dc83e6.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 |
|---|
| 67405-500-03 | 67405050003 | 30 TABLET in 1 BOTTLE (67405-500-03) | 30 tablet | 2014-08-13 | 0000-00-00 | No | No | Current |
| 67405-500-10 | 67405050010 | 100 TABLET in 1 BOTTLE (67405-500-10) | 100 tablet | 2014-08-13 | 0000-00-00 | No | No | Current |