Terbinafine hydrochloride

Drug ingredient

CAS 78628-80-5

This chemical is an active pharmaceutical ingredient used in FDA-regulated drugs.

Molecular structure of 78628-80-5
1 HCl
US productionNot reported
Import value, 2024$41M
Top sourceIndia 37%

This chemical is not on EPA’s Toxic Substances Control Act inventory, the list behind EPA’s production survey.

Why supply is unknown

Production is reported production, not a complete census of factories. Import value and source-country shares describe a shared customs category, not a separate chemical measurement.

Where It Comes From

Customs basis: HS 292149 · basket

These shares come from HS customs code 292149, which covers 80 tracked chemicals in total. They estimate the category's origin mix, not this chemical specifically.

Source Countries
IN 37%IndiaCN 25%ChinaDE 14%GermanyMX 9%MexicoGB 4%United Kingdom
60 FDA-registered drug labelers
A-S Medication Solutions
Alivus Life Sciences Limited
American Health Packaging
AmerisourceBergen
Amici Pharma, Inc.
Aphena Pharma Solutions - Tennessee, LLC
Aurobindo Pharma Limited
Beautivity LLC
Bionpharma Inc.
Breckenridge Pharmaceutical, Inc.
Bryant Ranch Prepack
Cardinal Health, 110 dba LEADER
Chartwell RX, LLC
Chromo Laboratories India Private Limited
Cipla Ltd.
Cipla USA Inc.
CVS Pharmacy
Darmerica, LLC
Derivados Quimicos
Derivados Quimicos SAU
direct rx
Dr.Reddy's Laboratories Limited
Exelan Pharmaceuticals Inc.
F.I.S. FABBRICA ITALIANA SINTETICI S.P.A.
Genomma Lab USA, Inc.
Golden State Medical Supply, Inc.
H E B
Hetero Labs Limited
Honour Lab Limited
Kalchem International inc
Karo Healthcare Inc.
Kroger Company
Laboratorios Liconsa SAU
LETCO MEDICAL, LLC
Little Pharma, Inc.
Medisca Inc,
Meijer Distribution Inc
MSN Laboratories Private Limited
NorthStar Rx LLC
Northwind Health Company, LLC
NuCare Pharmaceuticals,Inc.
PD-Rx Pharmaceuticals, Inc.
Preferred Pharmaceuticals Inc.
Professional Compounding Centers of America
Professional Compounding Centers of America dba PCCA
Proficient Rx LP
Publix Super Markets Inc.
Quimica Sintetica S.A.
REMEDYREPACK INC.
Rite Aid Corporation
Scholl's Wellness Company LLC
Shandong Anhong Pharmaceutical Co., Ltd.
Shenzhen Xinxin Yunhai Technology Co., Ltd.
STRATEGIC SOURCING SERVICES LLC
Sun Pharmaceutical Industries, Inc.
UQUIFA Mexico, S.A. DE C.V.
Vijayasri Organics Private Limited
Voyant Beauty Inc.
Wal-Mart Stores Inc
WALGREEN COMPANY

Why It Matters

Sectors
Health
Downstream Uses

Appears in 18 drug and cosmetic product listings (FDA).

  • •Pharmbanner Tinea Versicolor Cream
  • •Lamisil AT
  • •Lamisil AT Cream
  • •Terbinafine
  • •Good Neighbor Pharmacy
  • •Kroger Antifungal
  • •CVS
  • •Terbinafine Hydrochloride
FDA Shortage Status
No FDA shortage records

Chemical Identity

CAS78628-80-5
PubChem CID5282481
DTXSIDDTXSID90229223
FormulaC21H26ClN
Mol. Weight327.9 g/mol
SMILESCC(C)(C)C#CC=CCN(C)CC1=CC=CC2=CC=CC=C21.Cl

Data Sources

Brief citations

Terbinafine hydrochloride (CAS 78628-80-5) https://chemicalindependence.com/chemical/78628-80-5/ PubChem: 5282481. Retrieved 2026-04-07. https://pubchem.ncbi.nlm.nih.gov/compound/5282481 FDA National Drug Code directory: CAS 78628-80-5. Retrieved 2026-04-25. https://open.fda.gov/data/ndc/ FDA National Drug Code directory: bulk match. Retrieved 2026-04-07. https://open.fda.gov/data/ndc/ US Census international trade: HS 292149 for CAS 78628-80-5. Reporting year: 2024. https://usatrade.census.gov/