Home NDC 50090-7300 terbinafine hydrochloride
Product NDC 50090-7300
11-digit product format 500907300
Labeler code 50090
Product ID 50090-7300_89a89899-6387-409a-b941-51a374183b43
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name terbinafine hydrochloride
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA078163
Marketing category ANDA
Marketing start 2022-01-28
Substance TERBINAFINE HYDROCHLORIDE
Active strength 250 mg/1
Pharmacologic classes Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A078163-001 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 A078163-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078163-001 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 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078163-001 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 A078163-001 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 A078163-001 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 A078163-001 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 A078163-001 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 A078163-001 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 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078163-001 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 A078163-001 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 A078163-001 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 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078163-001 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 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078163-001 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 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078163-001 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 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078163-001 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 A078163-001 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 A078163-001 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 A078163-001 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 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078163-001 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 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078163-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base terbinafine hydrochloride
Listing expiration 2026-12-31 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 50090-7300-0 terbinafine hydrochloride 30 in 1 BOTTLE TABLET 30 1 50090-7300-1 terbinafine hydrochloride 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-7300 TERBINAFINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS] 1 Current NDC, 2 package rows 20241016_8f6d7b1a-5a01-4cc5-b5b7-c126ae889557.zip
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 · 5 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 50090-7300-0 50090730000 30 TABLET in 1 BOTTLE (50090-7300-0) 30 tablet 2024-10-14 No No Current 50090-7300-1 50090730001 90 TABLET in 1 BOTTLE (50090-7300-1) 90 tablet 2024-10-14 No No Current