Terbinafine Hydrochloride
- Product NDC
- 68151-1327
- 11-digit product format
- 681511327
- Labeler code
- 68151
- Product ID
- 68151-1327_d277a6e5-f60f-4265-998d-6c662617d7b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbinafine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Carilion Materials Management
- Application
- ANDA077533
- Marketing category
- ANDA
- Marketing start
- 2011-01-01
- Marketing end
- 0000-00-00
- Substance
- TERBINAFINE HYDROCHLORIDE
- Active strength
- 250 1/1
- Pharmacologic classes
- Allylamine [CS],Allylamine Antifungal [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 55a24767-1759-5f6a-8888-ea4aa0adac21 | Product name | 1 | 20140508 |
| db9701af-cb4f-b8ba-d282-6bc5b6b7c467 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68151-1327-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a08d-f424-e053-dadaa90a57ce | Terbinafine tablets, USP 250 mg for oral use These highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Terbinafine Hydrochloride. Terbinafine Hydrochloride (Terbinafine Hydrochloride) TABLET for ORAL use. Initial U.S. Approval: 1992 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68151-1327-0 | Terbinafine Hydrochloride | 1 in 1 PACKAGE | TABLET | 1 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TERBINAFINE HYDROCHLORIDE | ACTIVE INGREDIENT | 012C11ZU6G | TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| TERBINAFINE | ACTIVE MOIETY | G7RIW8S0XP | TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68151-1327 | TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT] | 2 | Legacy NDC, 1 package rows | 20140828_984ad737-0cfe-4bee-888d-3a07b23cb7cd.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313222 | terbinafine HCl 250 MG Oral Tablet | PSN | 984ad737-0cfe-4bee-888d-3a07b23cb7cd | 2 |
| 313222 | terbinafine 250 MG Oral Tablet | SCD | 984ad737-0cfe-4bee-888d-3a07b23cb7cd | 2 |
| 313222 | terbinafine (as terbinafine HCl) 250 MG Oral Tablet | SY | 984ad737-0cfe-4bee-888d-3a07b23cb7cd | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68151-1327-0 | 68151132700 | 1 in 1 PACKAGE | Historical |