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NDC 43063-0906-20 Terbinafine Hydrochloride 250 mg/1 Details
Terbinafine Hydrochloride 250 mg/1
Terbinafine Hydrochloride is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PD-Rx Pharmaceuticals, Inc.. The primary component is TERBINAFINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Terbinafine granules are used to treat fungal infections of the scalp. Terbinafine tablets are used to treat fungal infections of the toenails and fingernails. Terbinafine is in a class of medications called antifungals. It works by stopping the growth of fungi.
Related Packages: 43063-0906-20Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Terbinafine
Product Information
| NDC | 43063-0906 |
|---|---|
| Product ID | 43063-906_ffec24cf-7659-f9c2-e053-6394a90a3294 |
| Associated GPIs | 11000080100310 |
| GCN Sequence Number | 018638 |
| GCN Sequence Number Description | terbinafine HCl TABLET 250 MG ORAL |
| HIC3 | W3B |
| HIC3 Description | ANTIFUNGAL AGENTS |
| GCN | 60823 |
| HICL Sequence Number | 007590 |
| HICL Sequence Number Description | TERBINAFINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Terbinafine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Terbinafine Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 250 |
| Active Ingredient Units | mg/1 |
| Substance Name | TERBINAFINE HYDROCHLORIDE |
| Labeler Name | PD-Rx Pharmaceuticals, Inc. |
| Pharmaceutical Class | Allylamine Antifungal [EPC], Allylamine [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077714 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43063-0906-20 (43063090620)
| NDC Package Code | 43063-906-20 |
|---|---|
| Billing NDC | 43063090620 |
| Package | 20 TABLET in 1 BOTTLE, PLASTIC (43063-906-20) |
| Marketing Start Date | 2019-02-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |