Home NDC 87564-010-10 TERBINAFINE
Product NDC 87564-010
Requested package NDC 87564-010-10
11-digit product format 875640010
Labeler code 87564
Product ID 87564-010_584d1fba-8315-2afa-e063-6394a90a9564
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name terbinafine hydrochloride tablet
Dosage form TABLET
Route ORAL
Labeler Amerisyn LLC
Application ANDA076390
Marketing category ANDA
Marketing start 2026-08-03
Substance TERBINAFINE HYDROCHLORIDE
Active strength 250 mg/1
Pharmacologic classes Allylamine Antifungal [EPC]; Allylamine [CS]
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076390-001 TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076390-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base TERBINAFINE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TERBINAFINE HYDROCHLORIDE 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 012C11ZU6G Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 87564-010-10 87564001010 100 TABLET in 1 BOTTLE (87564-010-10) 100 tablet 2026-08-03 0 Current