tetrabenazine

Product NDC
68682-422
11-digit product format
686820422
Labeler code
68682
Product ID
68682-422_66a8dcef-cfb3-484a-a213-658943881951
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tetrabenazine
Dosage form
TABLET
Route
ORAL
Labeler
Oceanside Pharmaceuticals
Application
NDA021894
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-07-20
Marketing end
2028-01-31
Substance
TETRABENAZINE
Active strength
25 mg/1
Pharmacologic classes
Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
tetrabenazine

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRABENAZINE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ9O08YRN8O
Rxcui199592, 805464

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dd868135-b25c-abb7-9326-3e7691e6893fProduct name820200611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68682-422-25tetrabenazine112 in 1 BOTTLETABLET1129

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-422-25EA - Each68682-422685620ba-3c85-4020-a2e9-abb6ee9f276e12015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TETRABENAZINEACTIVE INGREDIENTZ9O08YRN8OTETRABENAZINE TABLET [OCEANSIDE PHARMACEUTICALS]2
TETRABENAZINEACTIVE MOIETYZ9O08YRN8OTETRABENAZINE TABLET [OCEANSIDE PHARMACEUTICALS]2
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTTETRABENAZINE TABLET [OCEANSIDE PHARMACEUTICALS]2
lactoseINACTIVE INGREDIENTJ2B2A4N98GTETRABENAZINE TABLET [OCEANSIDE PHARMACEUTICALS]2
magnesium stearateINACTIVE INGREDIENT70097M6I30TETRABENAZINE TABLET [OCEANSIDE PHARMACEUTICALS]2
starch, cornINACTIVE INGREDIENTO8232NY3SJTETRABENAZINE TABLET [OCEANSIDE PHARMACEUTICALS]2
talcINACTIVE INGREDIENT7SEV7J4R1UTETRABENAZINE TABLET [OCEANSIDE PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-422TETRABENAZINE TABLET [OCEANSIDE PHARMACEUTICALS]8Current NDC, Legacy NDC, 1 package rows20200121_5867189c-17bd-4e70-a079-c4730f9950d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
805464tetrabenazine 12.5 MG Oral TabletPSN5867189c-17bd-4e70-a079-c4730f9950d19
199592tetrabenazine 25 MG Oral TabletPSN5867189c-17bd-4e70-a079-c4730f9950d19
805464tetrabenazine 12.5 MG Oral TabletSCD5867189c-17bd-4e70-a079-c4730f9950d19
199592tetrabenazine 25 MG Oral TabletSCD5867189c-17bd-4e70-a079-c4730f9950d19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68682-422-2568682042225112 TABLET in 1 BOTTLE (68682-422-25) 112 tablet2015-07-202028-01-31NoNoCurrent