Lamotrigine

Product NDC
0093-7248
11-digit product format
000937248
Labeler code
0093
Product ID
0093-7248_bfe86f59-2ea1-4ba4-a652-e005bcff313c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA076388
Marketing category
ANDA
Marketing start
2008-07-22
Marketing end
2019-12-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
14a9502b-3d70-0496-a7e1-b16edaa005b8Product name520250423
16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0Product name720250401
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6aProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7248-05EA - Each0093-72483d9c5452-27d0-478d-b0ff-3db411f3986212012-07-24
0093-7248-06EA - Each0093-7248ab8237b0-2c60-4679-83eb-35fb17d44bb212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [PHYSICIANS TOTAL CARE, INC.]10
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [PHYSICIANS TOTAL CARE, INC.]10
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LAMOTRIGINE TABLET [PHYSICIANS TOTAL CARE, INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [PHYSICIANS TOTAL CARE, INC.]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLAMOTRIGINE TABLET [PHYSICIANS TOTAL CARE, INC.]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LAMOTRIGINE TABLET [PHYSICIANS TOTAL CARE, INC.]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLAMOTRIGINE TABLET [PHYSICIANS TOTAL CARE, INC.]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [PHYSICIANS TOTAL CARE, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [PHYSICIANS TOTAL CARE, INC.]10
POVIDONE K30INACTIVE INGREDIENTU725QWY32XLAMOTRIGINE TABLET [PHYSICIANS TOTAL CARE, INC.]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LAMOTRIGINE TABLET [PHYSICIANS TOTAL CARE, INC.]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET [PHYSICIANS TOTAL CARE, INC.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLAMOTRIGINE TABLET [PHYSICIANS TOTAL CARE, INC.]10
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [STAT RX USA LLC]1
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [STAT RX USA LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLAMOTRIGINE TABLET [STAT RX USA LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LAMOTRIGINE TABLET [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [STAT RX USA LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ELAMOTRIGINE TABLET [STAT RX USA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LAMOTRIGINE TABLET [STAT RX USA LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET [STAT RX USA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLAMOTRIGINE TABLET [STAT RX USA LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSN6c925a5d-e154-475c-8478-ab7a271d68b910
198428lamoTRIgine 150 MG Oral TabletPSN6c925a5d-e154-475c-8478-ab7a271d68b910
198429lamoTRIgine 200 MG Oral TabletPSN6c925a5d-e154-475c-8478-ab7a271d68b910
282401lamoTRIgine 25 MG Oral TabletPSN6c925a5d-e154-475c-8478-ab7a271d68b910
198427lamotrigine 100 MG Oral TabletSCD6c925a5d-e154-475c-8478-ab7a271d68b910
198428lamotrigine 150 MG Oral TabletSCD6c925a5d-e154-475c-8478-ab7a271d68b910
198429lamotrigine 200 MG Oral TabletSCD6c925a5d-e154-475c-8478-ab7a271d68b910
282401lamotrigine 25 MG Oral TabletSCD6c925a5d-e154-475c-8478-ab7a271d68b910
198427lamoTRIgine 100 MG Oral TabletPSN11800356-759d-4a8d-8811-e7942a3db6f51
198429lamoTRIgine 200 MG Oral TabletPSN11800356-759d-4a8d-8811-e7942a3db6f51
198427lamotrigine 100 MG Oral TabletSCD11800356-759d-4a8d-8811-e7942a3db6f51
198429lamotrigine 200 MG Oral TabletSCD11800356-759d-4a8d-8811-e7942a3db6f51