FDA.reportPublic FDA data

Lamotrigine

Product NDC
29300-114
11-digit product format
293000114
Labeler code
29300
Product ID
29300-114_03f59daf-b60e-46d1-b121-6a39361ee4f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA090170
Marketing category
ANDA
Marketing start
2011-11-01
Substance
LAMOTRIGINE
Active strength
200 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMOTRIGINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui198427, 198428, 198429, 282401

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29300-114-05Lamotrigine500 in 1 BOTTLE, PLASTICTABLET50024
29300-114-10Lamotrigine1000 in 1 BOTTLE, PLASTICTABLET100024
29300-114-16Lamotrigine60 in 1 BOTTLE, PLASTICTABLET6024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-114-05EA - Each29300-114e77983d9-3f2c-4f03-a8cf-2e8cbb3bbadc12013-02-13
29300-114-16EA - Each29300-11462b5ba6c-f48f-4497-8166-da23ba4ddd7a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]7
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]7
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQLAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]7
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [DIRECT RX]1
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [DIRECT RX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLAMOTRIGINE TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [DIRECT RX]1
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQLAMOTRIGINE TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-114LAMOTRIGINE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]22Current NDC, Legacy NDC, 3 package rows20250529_4b72ea7a-a0b0-4980-84ad-84f64e2e6368.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198429lamoTRIgine 200 MG Oral TabletPSN812bc0d8-bb31-4fb1-9f4a-f8c17cbc769c102
198429lamotrigine 200 MG Oral TabletSCD812bc0d8-bb31-4fb1-9f4a-f8c17cbc769c102
198427lamoTRIgine 100 MG Oral TabletPSN4b72ea7a-a0b0-4980-84ad-84f64e2e636824
198428lamoTRIgine 150 MG Oral TabletPSN4b72ea7a-a0b0-4980-84ad-84f64e2e636824
198429lamoTRIgine 200 MG Oral TabletPSN4b72ea7a-a0b0-4980-84ad-84f64e2e636824
282401lamoTRIgine 25 MG Oral TabletPSN4b72ea7a-a0b0-4980-84ad-84f64e2e636824
198427lamotrigine 100 MG Oral TabletSCD4b72ea7a-a0b0-4980-84ad-84f64e2e636824
198428lamotrigine 150 MG Oral TabletSCD4b72ea7a-a0b0-4980-84ad-84f64e2e636824
198429lamotrigine 200 MG Oral TabletSCD4b72ea7a-a0b0-4980-84ad-84f64e2e636824
282401lamotrigine 25 MG Oral TabletSCD4b72ea7a-a0b0-4980-84ad-84f64e2e636824
198429lamoTRIgine 200 MG Oral TabletPSN346f8af3-b850-48e4-bd6e-82ecafca86d215
198429lamoTRIgine 200 MG Oral TabletPSN3ed4590d-71e3-4208-b6c0-98330acc7b8515
198429lamotrigine 200 MG Oral TabletSCD346f8af3-b850-48e4-bd6e-82ecafca86d215
198429lamotrigine 200 MG Oral TabletSCD3ed4590d-71e3-4208-b6c0-98330acc7b8515
198429lamoTRIgine 200 MG Oral TabletPSN84277e2c-370c-4510-92bc-ef33a4a0f50812
198429lamotrigine 200 MG Oral TabletSCD84277e2c-370c-4510-92bc-ef33a4a0f50812
198429lamoTRIgine 200 MG Oral TabletPSN6f7e59d2-4311-42a0-93a0-b29b0417d96f1
198429lamoTRIgine 200 MG Oral TabletPSN8ac9dc83-edb2-4ae5-8064-40f113fd3aab1
198429lamoTRIgine 200 MG Oral TabletPSN0b9da408-7857-4ff8-86f9-ae56bfd0fe381
198429lamotrigine 200 MG Oral TabletSCD8ac9dc83-edb2-4ae5-8064-40f113fd3aab1
198429lamotrigine 200 MG Oral TabletSCD6f7e59d2-4311-42a0-93a0-b29b0417d96f1
198429lamotrigine 200 MG Oral TabletSCD0b9da408-7857-4ff8-86f9-ae56bfd0fe381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-114-0529300011405500 TABLET in 1 BOTTLE, PLASTIC (29300-114-05) 500 tablet2011-11-010000-00-00NoNoCurrent
29300-114-10293000114101000 TABLET in 1 BOTTLE, PLASTIC (29300-114-10) 1000 tablet2011-11-010000-00-00NoNoCurrent
29300-114-162930001141660 TABLET in 1 BOTTLE, PLASTIC (29300-114-16) 60 tablet2011-11-010000-00-00NoNoCurrent