FDA.reportPublic FDA data

Lamotrigine

Product NDC
55111-719
11-digit product format
551110719
Labeler code
55111
Product ID
55111-719_236437dc-fce9-b140-992c-b7822562eee5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lamotrigine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Dr.Reddy's Laboratories Limited
Application
ANDA202383
Marketing category
ANDA
Marketing start
2013-06-20
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lamotrigine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMOTRIGINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui850087, 850091, 900156, 900164, 1098608, 1146690

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
55111-719-05Lamotrigine500 in 1 BOTTLETABLET, EXTENDED RELEASE50029
55111-719-30Lamotrigine30 in 1 BOTTLETABLET, EXTENDED RELEASE3029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-719-30EA - Each55111-719d7e197f0-0f8c-43c4-b829-3e28b42f24cc12013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]15
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]15
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]15
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]15
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]15
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]15
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]15
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JLAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]15
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]15
SHELLACINACTIVE INGREDIENT46N107B71OLAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]15
TALCINACTIVE INGREDIENT7SEV7J4R1ULAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]15
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMLAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-719LAMOTRIGINE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LIMITED]27Current NDC, Legacy NDC, 2 package rows20210528_a69542ea-5b6f-15c1-9e7a-90ac839971d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
850087lamoTRIgine 100 MG 24HR Extended Release Oral TabletPSNa69542ea-5b6f-15c1-9e7a-90ac839971d329
900156lamoTRIgine 200 MG 24HR Extended Release Oral TabletPSNa69542ea-5b6f-15c1-9e7a-90ac839971d329
900164lamoTRIgine 25 MG 24HR Extended Release Oral TabletPSNa69542ea-5b6f-15c1-9e7a-90ac839971d329
1146690lamoTRIgine 250 MG 24HR Extended Release Oral TabletPSNa69542ea-5b6f-15c1-9e7a-90ac839971d329
1098608lamoTRIgine 300 MG 24HR Extended Release Oral TabletPSNa69542ea-5b6f-15c1-9e7a-90ac839971d329
850091lamoTRIgine 50 MG 24HR Extended Release Oral TabletPSNa69542ea-5b6f-15c1-9e7a-90ac839971d329
85008724 HR lamotrigine 100 MG Extended Release Oral TabletSCDa69542ea-5b6f-15c1-9e7a-90ac839971d329
90015624 HR lamotrigine 200 MG Extended Release Oral TabletSCDa69542ea-5b6f-15c1-9e7a-90ac839971d329
90016424 HR lamotrigine 25 MG Extended Release Oral TabletSCDa69542ea-5b6f-15c1-9e7a-90ac839971d329
114669024 HR lamotrigine 250 MG Extended Release Oral TabletSCDa69542ea-5b6f-15c1-9e7a-90ac839971d329
109860824 HR lamotrigine 300 MG Extended Release Oral TabletSCDa69542ea-5b6f-15c1-9e7a-90ac839971d329
85009124 HR lamotrigine 50 MG Extended Release Oral TabletSCDa69542ea-5b6f-15c1-9e7a-90ac839971d329
850087lamotrigine 100 MG 24 HR Extended Release Oral TabletSYa69542ea-5b6f-15c1-9e7a-90ac839971d329
900156lamotrigine 200 MG 24 HR Extended Release Oral TabletSYa69542ea-5b6f-15c1-9e7a-90ac839971d329
900164lamotrigine 25 MG 24 HR Extended Release Oral TabletSYa69542ea-5b6f-15c1-9e7a-90ac839971d329
1146690lamotrigine 250 MG 24 HR Extended Release Oral TabletSYa69542ea-5b6f-15c1-9e7a-90ac839971d329
1098608lamotrigine 300 MG 24 HR Extended Release Oral TabletSYa69542ea-5b6f-15c1-9e7a-90ac839971d329
850091lamotrigine 50 MG 24 HR Extended Release Oral TabletSYa69542ea-5b6f-15c1-9e7a-90ac839971d329

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55111-719-0555111071905500 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-719-05) 2013-06-200000-00-00NoNoCurrent
55111-719-305511107193030 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-719-30) 2013-06-200000-00-00NoNoCurrent