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NDC 70000-0338-01 Terbinafine Hydrochloride 1 g/100g Details
Terbinafine Hydrochloride 1 g/100g
Terbinafine Hydrochloride is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health, 110 dba LEADER. The primary component is TERBINAFINE HYDROCHLORIDE.
Product Information
| NDC | 70000-0338 |
|---|---|
| Product ID | 70000-0338_2d2e23c4-e450-485f-aa1a-17f160d979e3 |
| Associated GPIs | 90150087103710 |
| GCN Sequence Number | 018273 |
| GCN Sequence Number Description | terbinafine HCl CREAM (G) 1 % TOPICAL |
| HIC3 | Q5F |
| HIC3 Description | TOPICAL ANTIFUNGALS |
| GCN | 62498 |
| 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 OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | g/100g |
| Substance Name | TERBINAFINE HYDROCHLORIDE |
| Labeler Name | Cardinal Health, 110 dba LEADER |
| Pharmaceutical Class | Allylamine Antifungal [EPC], Allylamine [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077511 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 70000-0338-01 (70000033801)
| NDC Package Code | 70000-0338-1 |
|---|---|
| Billing NDC | 70000033801 |
| Package | 1 TUBE in 1 CARTON (70000-0338-1) / 15 g in 1 TUBE |
| Marketing Start Date | 2018-07-30 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.39521 |
| Pricing Unit | GM |
| Effective Date | 2024-02-21 |
| NDC Description | ATHLETE'S FOOT 1% CREAM |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL a9412747-c7f9-4242-91ed-3695f372f6c9 Details
Uses
Warnings
Directions
- adults and children 12 years and over:
- use the tip of the cap to break the seal and open the tube
- wash the affected skin with soap and water and dry completely before applying
-
for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
- between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor
- on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor
- for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor
- wash hands after each use
- children under 12 years: ask a doctor
| 1 week between the toes | 2 weeks on the bottom or sides of the foot |
 |  |
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
INGREDIENTS AND APPEARANCE
| TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride cream |
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| Labeler - Cardinal Health, 110 dba LEADER (063997360) |
Revised: 6/2021
Document Id: 2d2e23c4-e450-485f-aa1a-17f160d979e3
Set id: a9412747-c7f9-4242-91ed-3695f372f6c9
Version: 2
Effective Time: 20210621