Home NDC 55111-250 Terbinafine Hydrochloride
Product NDC 55111-250
11-digit product format 551110250
Labeler code 55111
Product ID 55111-250_9c427fa5-f0ef-593a-376a-0de7943c4057
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Terbinafine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Dr.Reddys Laboratories Limited
Application ANDA076390
Marketing category ANDA
Marketing start 2007-07-02
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 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 · 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 A076390-001 TERBINAFINE HYDROCHLORIDE EQ 250MG BASE TABLET / ORAL AB 2007-07-02 caaa826d4ba7…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…
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 55111-250-01 Terbinafine Hydrochloride 100 in 1 BOTTLE TABLET 100 8 55111-250-05 Terbinafine Hydrochloride 500 in 1 BOTTLE TABLET 500 8 55111-250-30 Terbinafine Hydrochloride 30 in 1 BOTTLE TABLET 30 8 55111-250-78 Terbinafine Hydrochloride 10 in 1 BLISTER PACK TABLET 10 8 55111-250-79 Terbinafine Hydrochloride 10 in 1 CARTON TABLET 10 8 55111-250-90 Terbinafine Hydrochloride 90 in 1 BOTTLE TABLET 90 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-250 TERBINAFINE HYDROCHLORIDE (TERBINAFINE HYDROCHLORIDE) TABLET [DR.REDDYS LABORATORIES LIMITED] 8 Current NDC, Legacy NDC, 6 package rows 20241222_e0b309a5-bebe-c6da-2847-bda21aa488b1.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55111-250-01 55111025001 100 TABLET in 1 BOTTLE (55111-250-01) 100 tablet 2007-07-02 0000-00-00 No No Current 55111-250-05 55111025005 500 TABLET in 1 BOTTLE (55111-250-05) 500 tablet 2007-07-02 0000-00-00 No No Current 55111-250-30 55111025030 30 TABLET in 1 BOTTLE (55111-250-30) 30 tablet 2007-07-02 0000-00-00 No No Current 55111-250-78 55111025078 10 in 1 BLISTER PACK Historical 55111-250-79 55111025079 10 BLISTER PACK in 1 CARTON (55111-250-79) / 10 TABLET in 1 BLISTER PACK (55111-250-78) 10 blister pack 2007-07-02 0000-00-00 No No Current 55111-250-90 55111025090 90 TABLET in 1 BOTTLE (55111-250-90) 90 tablet 2007-07-02 0000-00-00 No No Current