FDA.reportPublic FDA data

Lamotrigine

Product NDC
29300-112
11-digit product format
293000112
Labeler code
29300
Product ID
29300-112_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
100 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
LAMOTRIGINE100 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
29300-112-01Lamotrigine100 in 1 BOTTLE, PLASTICTABLET10024
29300-112-05Lamotrigine500 in 1 BOTTLE, PLASTICTABLET50024
29300-112-10Lamotrigine1000 in 1 BOTTLE, PLASTICTABLET100024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-112-01EA - Each29300-1127162690a-a4bd-4c4c-aa21-a0fd3a3a26a112013-02-13
29300-112-05EA - Each29300-11209d58412-cb2a-4d94-afe7-da2450580fb712013-02-13
29300-112-10EA - Each29300-11269c02a33-4c55-4cd4-ad07-0da6b4e01f3412013-02-13

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 [TYA PHARMACEUTICALS]4
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [TYA PHARMACEUTICALS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [TYA PHARMACEUTICALS]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [TYA PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [TYA PHARMACEUTICALS]4
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQLAMOTRIGINE TABLET [TYA PHARMACEUTICALS]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET [TYA PHARMACEUTICALS]4
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [DIRECT RX]1
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [DIRECT RX]1
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQLAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]1
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQLAMOTRIGINE TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET [AIDAREX PHARMACEUTICALS LLC]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
29300-112LAMOTRIGINE 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
198427lamoTRIgine 100 MG Oral TabletPSN6139a858-700c-4eb9-9f84-99d280bde32628
198428lamoTRIgine 150 MG Oral TabletPSN6139a858-700c-4eb9-9f84-99d280bde32628
282401lamoTRIgine 25 MG Oral TabletPSN6139a858-700c-4eb9-9f84-99d280bde32628
198427lamotrigine 100 MG Oral TabletSCD6139a858-700c-4eb9-9f84-99d280bde32628
198428lamotrigine 150 MG Oral TabletSCD6139a858-700c-4eb9-9f84-99d280bde32628
282401lamotrigine 25 MG Oral TabletSCD6139a858-700c-4eb9-9f84-99d280bde32628
198427lamoTRIgine 100 MG Oral TabletPSNdc6e6735-d49a-44d8-936d-7c33437bc59e27
198427lamotrigine 100 MG Oral TabletSCDdc6e6735-d49a-44d8-936d-7c33437bc59e27
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
198427lamoTRIgine 100 MG Oral TabletPSN53774022-ea0c-42a9-a720-dc755c77b85117
198427lamotrigine 100 MG Oral TabletSCD53774022-ea0c-42a9-a720-dc755c77b85117
198427lamoTRIgine 100 MG Oral TabletPSN09a0d30d-9b8f-4c76-8cdb-8492386b22549
198427lamotrigine 100 MG Oral TabletSCD09a0d30d-9b8f-4c76-8cdb-8492386b22549
198427lamoTRIgine 100 MG Oral TabletPSNf5761818-4eaf-4335-a77a-9cd703278ded5
198427lamotrigine 100 MG Oral TabletSCDf5761818-4eaf-4335-a77a-9cd703278ded5
198427lamoTRIgine 100 MG Oral TabletPSN52273d60-3f27-4846-bf40-014ebcf094174
198427lamoTRIgine 100 MG Oral TabletPSN05405214-6215-432a-aa53-f7e03f35c7b14
282401lamoTRIgine 25 MG Oral TabletPSN05405214-6215-432a-aa53-f7e03f35c7b14
198427lamotrigine 100 MG Oral TabletSCD52273d60-3f27-4846-bf40-014ebcf094174
198427lamotrigine 100 MG Oral TabletSCD05405214-6215-432a-aa53-f7e03f35c7b14
282401lamotrigine 25 MG Oral TabletSCD05405214-6215-432a-aa53-f7e03f35c7b14
198427lamoTRIgine 100 MG Oral TabletPSN86bf413c-f650-f995-e053-2991aa0ab3ce3
198427lamoTRIgine 100 MG Oral TabletPSNb71ea970-4d53-44c2-aaed-19f2b5d22ce33
198427lamoTRIgine 100 MG Oral TabletPSN610e58a0-81b2-4a44-9882-81bdcd690dca3
198427lamotrigine 100 MG Oral TabletSCD86bf413c-f650-f995-e053-2991aa0ab3ce3
198427lamotrigine 100 MG Oral TabletSCDb71ea970-4d53-44c2-aaed-19f2b5d22ce33
198427lamotrigine 100 MG Oral TabletSCD610e58a0-81b2-4a44-9882-81bdcd690dca3
198427lamoTRIgine 100 MG Oral TabletPSNed113525-f99c-70ab-e053-2995a90a062f2
198427lamotrigine 100 MG Oral TabletSCDed113525-f99c-70ab-e053-2995a90a062f2
198427lamoTRIgine 100 MG Oral TabletPSN6d3f37b6-ad2e-470e-be6a-3de98479a9411
198427lamoTRIgine 100 MG Oral TabletPSN52b8be5c-ef88-dfa7-e063-6394a90a05001
198427lamotrigine 100 MG Oral TabletSCD6d3f37b6-ad2e-470e-be6a-3de98479a9411
198427lamotrigine 100 MG Oral TabletSCD52b8be5c-ef88-dfa7-e063-6394a90a05001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-112-0129300011201100 TABLET in 1 BOTTLE, PLASTIC (29300-112-01) 100 tablet2011-11-010000-00-00NoNoCurrent
29300-112-0529300011205500 TABLET in 1 BOTTLE, PLASTIC (29300-112-05) 500 tablet2011-11-010000-00-00NoNoCurrent
29300-112-10293000112101000 TABLET in 1 BOTTLE, PLASTIC (29300-112-10) 1000 tablet2011-11-010000-00-00NoNoCurrent