Terbinafine Hydrochloride

Product NDC
51672-2080
11-digit product format
516722080
Labeler code
51672
Product ID
51672-2080_4b425c57-bf63-6851-e063-6394a90ac6e7
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077511
Marketing category
ANDA
Marketing start
2007-07-02
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
1 g/100g
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 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
A077511-001TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-023f01610625f2…
2019-09-15 20:21 UTC2019-09A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077511-001TERBINAFINE HYDROCHLORIDE1%CREAM / TOPICAL2007-07-02e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERBINAFINE HYDROCHLORIDE1 g/100g

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
992528Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
92b31fc4-0f02-4857-b11f-49b9f942ee84Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2080-1Terbinafine Hydrochloride15 g in 1 TUBECREAM156
51672-2080-1Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-2Terbinafine Hydrochloride30 g in 1 TUBECREAM306
51672-2080-2Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-3Terbinafine Hydrochloride60 g in 1 TUBECREAM606
51672-2080-3Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-4Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-4Terbinafine Hydrochloride15 g in 1 TUBECREAM156
51672-2080-6Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-6Terbinafine Hydrochloride45 g in 1 TUBECREAM456
51672-2080-8Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-8Terbinafine Hydrochloride12 g in 1 TUBECREAM126
51672-2080-9Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-9Terbinafine Hydrochloride24 g in 1 TUBECREAM246

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2080-1GM - Gram51672-20805b077eb2-4a3e-4467-b213-af80bebdfea212012-07-24
51672-2080-2GM - Gram51672-2080b99b56d3-5b68-429b-b864-d7cef0ee297012012-07-24
51672-2080-8GM - Gram51672-2080250969be-c2ab-423f-9beb-f2c9d68abc0512012-07-24
51672-2080-9GM - Gram51672-2080b03e439e-fc3f-496d-b719-b958636880ea12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
TerbinafineACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
cetyl alcoholINACTIVE INGREDIENT936JST6JCNTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08XTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32ITERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
TerbinafineACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
TerbinafineACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
TerbinafineACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08XTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08XTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08XTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ITERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ITERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ITERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
waterINACTIVE INGREDIENT059QF0KO0RTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
waterINACTIVE INGREDIENT059QF0KO0RTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
waterINACTIVE INGREDIENT059QF0KO0RTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2080TERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 14 package rows20210304_92b31fc4-0f02-4857-b11f-49b9f942ee84.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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEScholl's Wellness Company LLC31f59302-eaee-211b-e063-6294a90a08b02026-04-03WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.92b31fc4-0f02-4857-b11f-49b9f942ee842026-02-20WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
ndc (product): 51672-2080
Walgreens Athletes FootTERBINAFINE HYDROCHLORIDEWalgreen Companyd706c56f-0123-4a5a-8c85-240cbe6ef7a52025-11-26WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
CVSTERBINAFINE HYDROCHLORIDECVS Pharmacy17684ba2-3c2c-4259-84fa-3833f19e5a4d2025-11-25WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Good Neighbor PharmacyTERBINAFINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.0a9e890c-1eed-4fde-a484-852a4dd135c22025-10-17WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc6016e546-6c02-4af0-888c-c0899865c5f02025-09-30WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
CVS Pharmacy Athletes FootTERBINAFINE HYDROCHLORIDECVS Pharmacy98a4ed66-2813-49de-8cda-94c41cc3ca9f2025-09-25WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Athletes FootTERBINAFINE HYDROCHLORIDEPublix Super Markets Inc.58293d62-089d-49ab-b691-dfd705ac9a9c2025-09-25WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
equate Athletes FootTERBINAFINE HYDROCHLORIDEWal-Mart Stores Ince799c808-7c0f-482d-99d2-35fc34dbb2ea2025-08-14WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Good Neighbor PharmacyTERBINAFINE HYDROCHLORIDEAmerisourceBergen93ea9e7f-6914-4df2-8ca0-27c4538066232025-07-28WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Athletes FootTERBINAFINE HYDROCHLORIDERite Aid Corporationa7b0a70b-a117-48cf-a6bc-260be1dac1e72025-07-28WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC28a3ece3-78fb-4121-86a7-adc4a9d9540f2025-07-21WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Athletes FootTERBINAFINE HYDROCHLORIDEH E B28db9a27-4d23-48ef-b1f3-08b993948c112025-07-15WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Kroger AntifungalTERBINAFINE HYDROCHLORIDEKroger Company32e79416-5de4-4f06-9fff-f8c36a1ad5db2025-07-15WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDEWALGREEN COMPANY2ba1924b-9967-4adb-9061-d023ef44ab3e2025-07-10WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDECardinal Health, 110 dba LEADERa9412747-c7f9-4242-91ed-3695f372f6c92025-07-09WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Silka AntifungalTERBINAFINE HYDROCHLORIDEGenomma Lab USA, Inc.a32cf699-e63e-4bd3-a5af-9e1ba447e02e2025-07-02WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Silka Jock ItchTERBINAFINE HYDROCHLORIDEGenomma Lab USA, Inc.326d8586-042f-44f8-8530-e46b7b777bc32025-07-02WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
AntifungalTERBINAFINE HYDROCHLORIDEMeijer Distribution Inc9daf3136-74b6-4410-8256-cbc9dd700f612025-07-02WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511
Terbinafine HydrochlorideTERBINAFINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.ca9cd2bd-4805-4469-b754-01a7487b71a62025-07-01WarningsExact identifier
application applno (ANDA): 077511
application number: ANDA077511

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992528terbinafine HCl 1 % Topical CreamPSNef8370dc-8ca4-411d-87e1-dc6af319133014
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCDef8370dc-8ca4-411d-87e1-dc6af319133014
992528terbinafine hydrochloride 1 % Topical CreamSYef8370dc-8ca4-411d-87e1-dc6af319133014
992528terbinafine HCl 1 % Topical CreamPSN6016e546-6c02-4af0-888c-c0899865c5f09
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD6016e546-6c02-4af0-888c-c0899865c5f09
992528terbinafine hydrochloride 1 % Topical CreamSY6016e546-6c02-4af0-888c-c0899865c5f09
992528terbinafine HCl 1 % Topical CreamPSN92b31fc4-0f02-4857-b11f-49b9f942ee846
992528terbinafine HCl 1 % Topical CreamPSN76f7525d-2005-4da8-a795-50ede6236c686
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD92b31fc4-0f02-4857-b11f-49b9f942ee846
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD76f7525d-2005-4da8-a795-50ede6236c686
992528terbinafine hydrochloride 1 % Topical CreamSY92b31fc4-0f02-4857-b11f-49b9f942ee846
992528terbinafine hydrochloride 1 % Topical CreamSY76f7525d-2005-4da8-a795-50ede6236c686
992528terbinafine HCl 1 % Topical CreamPSN89afb1dc-a236-4154-b8b5-2cab6ad421c85
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD89afb1dc-a236-4154-b8b5-2cab6ad421c85
992528terbinafine hydrochloride 1 % Topical CreamSY89afb1dc-a236-4154-b8b5-2cab6ad421c85
992528terbinafine HCl 1 % Topical CreamPSNba1f253f-021b-4857-b015-a72aa9df2d832
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCDba1f253f-021b-4857-b015-a72aa9df2d832
992528terbinafine hydrochloride 1 % Topical CreamSYba1f253f-021b-4857-b015-a72aa9df2d832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2080-1516722080011 TUBE in 1 CARTON (51672-2080-1) / 15 g in 1 TUBE1 tube2007-07-020000-00-00NoNoCurrent
51672-2080-2516722080021 TUBE in 1 CARTON (51672-2080-2) / 30 g in 1 TUBE1 tube2007-07-020000-00-00NoNoCurrent
51672-2080-3516722080031 TUBE in 1 CARTON (51672-2080-3) / 60 g in 1 TUBE1 tube2007-07-020000-00-00NoNoCurrent
51672-2080-4516722080041 TUBE in 1 CARTON (51672-2080-4) / 15 g in 1 TUBE1 tube2017-04-240000-00-00NoNoCurrent
51672-2080-6516722080061 TUBE in 1 CARTON (51672-2080-6) / 45 g in 1 TUBE1 tube2007-07-020000-00-00NoNoCurrent
51672-2080-8516722080081 TUBE in 1 CARTON (51672-2080-8) / 12 g in 1 TUBE1 tube2007-07-020000-00-00NoNoCurrent
51672-2080-9516722080091 TUBE in 1 CARTON (51672-2080-9) / 24 g in 1 TUBE1 tube2007-07-020000-00-00NoNoCurrent