FDA.reportPublic FDA data

Lamotrigine

Product NDC
29300-111
11-digit product format
293000111
Labeler code
29300
Product ID
29300-111_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
25 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
LAMOTRIGINE25 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
29300-111-01Lamotrigine100 in 1 BOTTLE, PLASTICTABLET10024
29300-111-05Lamotrigine500 in 1 BOTTLE, PLASTICTABLET50024
29300-111-10Lamotrigine1000 in 1 BOTTLE, PLASTICTABLET100024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-111-01EA - Each29300-1118fcff413-0dff-41e2-8ef1-2377f2e4aa0012013-02-13
29300-111-05EA - Each29300-1115605df46-2a52-4d2b-9da3-ae6ff1f4cd1d12013-02-13
29300-111-10EA - Each29300-111932cc8be-0dd1-4f95-a1de-9c0aa1c56b1912013-02-13

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 [PROFICIENT RX LP]1
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [PROFICIENT RX LP]1
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQLAMOTRIGINE TABLET [PROFICIENT RX LP]1
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQLAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LAMOTRIGINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-111LAMOTRIGINE 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
282401lamoTRIgine 25 MG Oral TabletPSNb1601109-5c17-4482-9257-1e0be7546e8f102
282401lamotrigine 25 MG Oral TabletSCDb1601109-5c17-4482-9257-1e0be7546e8f102
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 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
282401lamoTRIgine 25 MG Oral TabletPSN1b5646a9-4724-44b8-8cd0-9c14f5e87f8622
282401lamotrigine 25 MG Oral TabletSCD1b5646a9-4724-44b8-8cd0-9c14f5e87f8622
282401lamoTRIgine 25 MG Oral TabletPSN16323699-9bf8-43c7-b3aa-5891563778728
282401lamotrigine 25 MG Oral TabletSCD16323699-9bf8-43c7-b3aa-5891563778728
282401lamoTRIgine 25 MG Oral TabletPSNdb5f7ee5-9bd9-1819-e053-2a95a90a91df6
282401lamotrigine 25 MG Oral TabletSCDdb5f7ee5-9bd9-1819-e053-2a95a90a91df6
282401lamoTRIgine 25 MG Oral TabletPSNb94ae2e4-e276-40c1-bc25-da980194fc995
282401lamotrigine 25 MG Oral TabletSCDb94ae2e4-e276-40c1-bc25-da980194fc995
198427lamoTRIgine 100 MG Oral TabletPSN05405214-6215-432a-aa53-f7e03f35c7b14
282401lamoTRIgine 25 MG Oral TabletPSN05405214-6215-432a-aa53-f7e03f35c7b14
198427lamotrigine 100 MG Oral TabletSCD05405214-6215-432a-aa53-f7e03f35c7b14
282401lamotrigine 25 MG Oral TabletSCD05405214-6215-432a-aa53-f7e03f35c7b14
282401lamoTRIgine 25 MG Oral TabletPSN0e7bca7a-a4a6-4b5a-9287-e1398532220c3
282401lamotrigine 25 MG Oral TabletSCD0e7bca7a-a4a6-4b5a-9287-e1398532220c3
282401lamoTRIgine 25 MG Oral TabletPSNa835b697-2beb-1ba8-e053-2995a90a470c2
282401lamoTRIgine 25 MG Oral TabletPSNdf63fe74-1225-0d83-e053-2995a90acca82
282401lamoTRIgine 25 MG Oral TabletPSNf7a86237-ece4-7cc4-e053-6294a90a13082
282401lamotrigine 25 MG Oral TabletSCDa835b697-2beb-1ba8-e053-2995a90a470c2
282401lamotrigine 25 MG Oral TabletSCDdf63fe74-1225-0d83-e053-2995a90acca82
282401lamotrigine 25 MG Oral TabletSCDf7a86237-ece4-7cc4-e053-6294a90a13082
282401lamoTRIgine 25 MG Oral TabletPSNd07bcc09-7679-4bc1-84be-83d86c26147f1
282401lamotrigine 25 MG Oral TabletSCDd07bcc09-7679-4bc1-84be-83d86c26147f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-111-0129300011101100 TABLET in 1 BOTTLE, PLASTIC (29300-111-01) 100 tablet2011-11-010000-00-00NoNoCurrent
29300-111-0529300011105500 TABLET in 1 BOTTLE, PLASTIC (29300-111-05) 500 tablet2011-11-010000-00-00NoNoCurrent
29300-111-10293000111101000 TABLET in 1 BOTTLE, PLASTIC (29300-111-10) 1000 tablet2011-11-010000-00-00NoNoCurrent