Home NDC 70518-4421 Terbinafine
Product NDC 70518-4421
11-digit product format 705184421
Labeler code 70518
Product ID 70518-4421_5b24a338-a25d-eedb-e063-6394a90a4440
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Terbinafine
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA077533
Marketing category ANDA
Marketing start 2025-08-04
Substance TERBINAFINE HYDROCHLORIDE
Active strength 250 mg/1
Pharmacologic classes Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A077533-001 TERBINAFINE HYDROCHLORIDE TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02
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 · 44 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 2026-10-15 13:18:30 2026-09 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL 2007-07-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077533-001 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 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077533-001 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 A077533-001 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 A077533-001 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 A077533-001 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 A077533-001 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 A077533-001 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 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077533-001 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 A077533-001 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 A077533-001 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 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077533-001 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 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077533-001 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 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077533-001 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 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077533-001 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 A077533-001 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 A077533-001 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 A077533-001 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 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077533-001 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 A077533-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 3a93d1ddd44b…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313222 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-4421-0 Terbinafine 90 in 1 BOTTLE, PLASTIC TABLET 90 4 70518-4421-1 Terbinafine 45 in 1 BOTTLE, PLASTIC TABLET 45 4 70518-4421-2 Terbinafine 30 in 1 BLISTER PACK TABLET 30 4 70518-4421-3 Terbinafine 30 in 1 BOTTLE, PLASTIC TABLET 30 4
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4421-0 70518442100 90 TABLET in 1 BOTTLE, PLASTIC (70518-4421-0) 90 tablet 2025-08-04 No No Current 70518-4421-1 70518442101 45 TABLET in 1 BOTTLE, PLASTIC (70518-4421-1) 45 tablet 2025-08-22 No No Current 70518-4421-2 70518442102 30 TABLET in 1 BLISTER PACK (70518-4421-2) 30 tablet 2025-09-02 No No Current 70518-4421-3 70518442103 30 TABLET in 1 BOTTLE, PLASTIC (70518-4421-3) 30 tablet 2025-09-10 No No Current