LAMOTRIGINE

Product NDC
69097-152
11-digit product format
690970152
Labeler code
69097
Product ID
69097-152_60f518f2-5321-454d-aef0-49b3b3f8a36d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA077783
Marketing category
ANDA
Marketing start
2010-11-01
Marketing end
0000-00-00
Substance
LAMOTRIGINE
Active strength
200 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-152-03EA - Each69097-15268759b8c-737c-4a2c-8286-e9e519172fb012015-04-03
69097-152-12EA - Each69097-152e796ba1f-e9ea-4aaa-844c-d323faf0776012015-04-03
69097-152-15EA - Each69097-15221499931-342d-4df8-98b0-fd20b1ed989b12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [CIPLA USA INC.]4
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [CIPLA USA INC.]4
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LAMOTRIGINE TABLET [CIPLA USA INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LAMOTRIGINE TABLET [CIPLA USA INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLAMOTRIGINE TABLET [CIPLA USA INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LAMOTRIGINE TABLET [CIPLA USA INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [CIPLA USA INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [CIPLA USA INC.]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XLAMOTRIGINE TABLET [CIPLA USA INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET [CIPLA USA INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-152LAMOTRIGINE TABLET [CIPLA USA INC.]15Legacy NDC20201007_ecfa700a-117e-44fc-90c9-bd96b46763cd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-152-026909701520230 TABLET in 1 BOTTLE (69097-152-02) 30 tablet2010-11-010000-00-00NoNoCurrent
69097-152-036909701520360 TABLET in 1 BOTTLE (69097-152-03) 60 tablet2010-11-010000-00-00NoNoCurrent
69097-152-1269097015212500 TABLET in 1 BOTTLE (69097-152-12) 500 tablet2010-11-010000-00-00NoNoCurrent
69097-152-15690970152151000 TABLET in 1 BOTTLE (69097-152-15) 1000 tablet2010-11-010000-00-00NoNoCurrent