FDA.reportPublic FDA data

Terbinafine

Product NDC
69097-859
11-digit product format
690970859
Labeler code
69097
Product ID
69097-859_e3db8f4b-ea51-41b6-859e-ad91677aaf73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA077533
Marketing category
ANDA
Marketing start
2016-06-27
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

Additional Listing Data#

Finished product
Yes
Brand name base
Terbinafine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERBINAFINE HYDROCHLORIDE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii012C11ZU6G
Rxcui313222

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
69097-859-02Terbinafine30 in 1 BOTTLETABLET306
69097-859-07Terbinafine100 in 1 BOTTLETABLET1006
69097-859-12Terbinafine500 in 1 BOTTLETABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-859-02EA - Each69097-85901aff9d5-b8f3-4ac0-98be-907fecb5439012016-07-19
69097-859-07EA - Each69097-859b9486c6a-6933-41d2-ba12-c37e1b020cf212016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-859TERBINAFINE TABLET [CIPLA USA INC.]5Current NDC, Legacy NDC, 3 package rows20201102_18b16aad-1877-4b07-b532-f0ef4843af91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN18b16aad-1877-4b07-b532-f0ef4843af916
313222terbinafine 250 MG Oral TabletSCD18b16aad-1877-4b07-b532-f0ef4843af916
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY18b16aad-1877-4b07-b532-f0ef4843af916
313222terbinafine HCl 250 MG Oral TabletPSNd6d9c5ec-440a-4700-8a52-d6bf6d6d90a55
313222terbinafine 250 MG Oral TabletSCDd6d9c5ec-440a-4700-8a52-d6bf6d6d90a55
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSYd6d9c5ec-440a-4700-8a52-d6bf6d6d90a55
313222terbinafine HCl 250 MG Oral TabletPSN3925dc10-ad66-46a8-bfa5-1a4314be35214
313222terbinafine HCl 250 MG Oral TabletPSNcacf5fe4-8c24-47ed-9a2b-b70aa5d45ef24
313222terbinafine 250 MG Oral TabletSCD3925dc10-ad66-46a8-bfa5-1a4314be35214
313222terbinafine 250 MG Oral TabletSCDcacf5fe4-8c24-47ed-9a2b-b70aa5d45ef24
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY3925dc10-ad66-46a8-bfa5-1a4314be35214
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSYcacf5fe4-8c24-47ed-9a2b-b70aa5d45ef24
313222terbinafine HCl 250 MG Oral TabletPSN14b441a7-67ea-4a90-bfeb-381bc10362a41
313222terbinafine HCl 250 MG Oral TabletPSN79ddc2e9-ea43-41a2-a5b0-b13b3eaf7d7a1
313222terbinafine 250 MG Oral TabletSCD79ddc2e9-ea43-41a2-a5b0-b13b3eaf7d7a1
313222terbinafine 250 MG Oral TabletSCD14b441a7-67ea-4a90-bfeb-381bc10362a41
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY79ddc2e9-ea43-41a2-a5b0-b13b3eaf7d7a1
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY14b441a7-67ea-4a90-bfeb-381bc10362a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-859-026909708590230 TABLET in 1 BOTTLE (69097-859-02) 30 tablet2016-06-270000-00-00NoNoCurrent
69097-859-0769097085907100 TABLET in 1 BOTTLE (69097-859-07) 100 tablet2016-06-270000-00-00NoNoCurrent
69097-859-1269097085912500 TABLET in 1 BOTTLE (69097-859-12) 500 tablet2016-06-270000-00-00NoNoCurrent