Terbinafine

Product NDC
70518-2941
Requested package NDC
70518-2941-0
11-digit product format
705182941
Labeler code
70518
Product ID
70518-2941_4ab97e93-0067-21d7-e063-6294a90ae00d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078297
Marketing category
ANDA
Marketing start
2020-11-13
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078297-001TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A078297-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-023f01610625f2…
2019-09-15 20:21 UTC2019-09A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-07-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078297-001TERBINAFINE HYDROCHLORIDEEQ 250MG BASETABLET / ORALABRS2007-07-02e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078297-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078297-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078297-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078297-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078297-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078297-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078297-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078297-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078297-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078297-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078297-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078297-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078297-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078297-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078297-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078297-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078297-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078297-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078297-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078297-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078297-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078297-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078297-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078297-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078297-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078297-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078297-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078297-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078297-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078297-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078297-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078297-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078297-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078297-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078297-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078297-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078297-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078297-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078297-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078297-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Terbinafine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERBINAFINE HYDROCHLORIDE250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
012C11ZU6GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313222Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
44c6f6e7-e0c0-450e-83ce-1ed4f3efddecAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
55a24767-1759-5f6a-8888-ea4aa0adac21Product name120140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2941-0Terbinafine30 in 1 BLISTER PACKTABLET305

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TerbinafineTERBINAFINE HYDROCHLORIDEAmerican Health Packaging4ee1b667-0cf6-46e4-a740-4fc27904d5772026-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078297
application number: ANDA078297
TerbinafineTERBINAFINE HYDROCHLORIDEREMEDYREPACK INC.44c6f6e7-e0c0-450e-83ce-1ed4f3efddec2026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078297
application number: ANDA078297
ndc (package): 70518-2941-0
ndc (product): 70518-2941
ndc11 (package): 70518294100
TerbinafineTERBINAFINE HYDROCHLORIDEA-S Medication Solutions5de4c245-7086-453b-b90a-7a1242ec2c0b2025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078297
application number: ANDA078297
TerbinafineTERBINAFINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.747fdc13-7c3a-4672-b50c-31c51037bda22025-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078297
application number: ANDA078297
TerbinafineTERBINAFINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.085e0809-6b7f-447e-976e-8276c29daad62025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078297
application number: ANDA078297
TerbinafineTERBINAFINE HYDROCHLORIDEBryant Ranch Prepack838c6140-19b6-4c2b-aed7-3065bd67af072025-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078297
application number: ANDA078297
TERBINAFINETERBINAFINEdirect rxc7cf55e2-f637-e2d9-e053-2995a90a62702025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078297
application number: ANDA078297
TerbinafineTERBINAFINE HYDROCHLORIDEProficient Rx LP0a54cc4f-0789-46ce-875f-df759aa95d9c2024-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078297
application number: ANDA078297
TerbinafineTERBINAFINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.87af930f-493c-590e-e053-2a95a90a804a2024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078297
application number: ANDA078297
TerbinafineTERBINAFINE HYDROCHLORIDEBryant Ranch Prepack294bc1af-50e3-4bff-8d48-321e673033ce2024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078297
application number: ANDA078297
TerbinafineTERBINAFINE HYDROCHLORIDEA-S Medication Solutions79a39fb1-12b7-4b1e-9f28-102af34d04592024-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078297
application number: ANDA078297
TerbinafineTERBINAFINE HYDROCHLORIDEAurobindo Pharma Limited6600e2b3-65df-4fc3-8081-d574537d27e32024-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078297
application number: ANDA078297
TerbinafineTERBINAFINE HYDROCHLORIDENorthStar Rx LLC8f87e3e1-4c9c-497a-af20-8ab52cfeef602024-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078297
application number: ANDA078297
TerbinafineTERBINAFINE HYDROCHLORIDEProficient Rx LP50657431-1cd9-42dd-9cfc-57db8713d2672024-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078297
application number: ANDA078297

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN44c6f6e7-e0c0-450e-83ce-1ed4f3efddec5
313222terbinafine 250 MG Oral TabletSCD44c6f6e7-e0c0-450e-83ce-1ed4f3efddec5
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY44c6f6e7-e0c0-450e-83ce-1ed4f3efddec5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2941-07051829410030 TABLET in 1 BLISTER PACK (70518-2941-0) 30 tablet2020-11-130000-00-00NoNoCurrent