TIAGABINE HYDROCHLORIDE

Product NDC
62756-200
11-digit product format
627560200
Labeler code
62756
Product ID
62756-200_57975e74-e45b-4fd9-9718-bfc9690acae5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TIAGABINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077555
Marketing category
ANDA
Marketing start
2011-11-04
Substance
TIAGABINE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIAGABINE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDQH6T6D8OY
Rxcui1299911, 1299917

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b72e14f-1cc2-c389-aef5-c9c0a7b93fb8Product name420220613

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-200-18TIAGABINE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10009
62756-200-83TIAGABINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-200-83EA - Each62756-2006c95b819-64d3-42cd-a802-7d235460029012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIAGABINE HYDROCHLORIDEACTIVE INGREDIENTDQH6T6D8OYTIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
TIAGABINEACTIVE MOIETYZ80I64HMNPTIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UTIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
TALCINACTIVE INGREDIENT7SEV7J4R1UTIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-200TIAGABINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]9Current NDC, Legacy NDC, 2 package rows20181102_7eeb2d81-c5d7-46a0-aa5c-149b55df71bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1299911tiaGABine HCl 2 MG Oral TabletPSN7eeb2d81-c5d7-46a0-aa5c-149b55df71bd9
1299917tiaGABine HCl 4 MG Oral TabletPSN7eeb2d81-c5d7-46a0-aa5c-149b55df71bd9
1299911tiagabine hydrochloride 2 MG Oral TabletSCD7eeb2d81-c5d7-46a0-aa5c-149b55df71bd9
1299917tiagabine hydrochloride 4 MG Oral TabletSCD7eeb2d81-c5d7-46a0-aa5c-149b55df71bd9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62756-200-18627560200181000 TABLET, FILM COATED in 1 BOTTLE (62756-200-18) 2011-11-040000-00-00NoNoCurrent
62756-200-836275602008330 TABLET, FILM COATED in 1 BOTTLE (62756-200-83) 2011-11-040000-00-00NoNoCurrent