FDA.reportPublic FDA data

LAMOTRIGINE

Product NDC
43063-203
11-digit product format
430630203
Labeler code
43063
Product ID
43063-203_508c7bfa-a4ab-5dcf-e063-6394a90a5402
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAMOTRIGINE
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078947
Marketing category
ANDA
Marketing start
2009-01-27
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
Rxcui198427

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
43063-203-30LAMOTRIGINE30 in 1 BOTTLE, PLASTICTABLET3027
43063-203-60LAMOTRIGINE60 in 1 BOTTLE, PLASTICTABLET6027
43063-203-90LAMOTRIGINE90 in 1 BOTTLE, PLASTICTABLET9027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-203-30EA - Each43063-20315d8aa4f-56fc-4c4c-a87e-5392553599ce12012-07-24
43063-203-60EA - Each43063-203a8dae20d-2459-48cf-913b-5c90e875ec8612019-04-11
43063-203-90EA - Each43063-2035fd1a60d-ab83-433e-8eb7-d0f6afb217f012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE (LAMOTRIGINE ) TABLET [PD-RX PHARMACEUTICALS, INC.]4
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE (LAMOTRIGINE ) TABLET [PD-RX PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-203LAMOTRIGINE TABLET [PD-RX PHARMACEUTICALS, INC.]25Current NDC, Legacy NDC, 3 package rows20240922_f31e1854-6068-4e45-b1e5-6def862fc466.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198427lamoTRIgine 100 MG Oral TabletPSNf31e1854-6068-4e45-b1e5-6def862fc46627
198427lamotrigine 100 MG Oral TabletSCDf31e1854-6068-4e45-b1e5-6def862fc46627

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-203-304306302033030 TABLET in 1 BOTTLE, PLASTIC (43063-203-30) 30 tablet2010-08-130000-00-00NoNoCurrent
43063-203-604306302036060 TABLET in 1 BOTTLE, PLASTIC (43063-203-60) 60 tablet2010-08-130000-00-00NoNoCurrent
43063-203-904306302039090 TABLET in 1 BOTTLE, PLASTIC (43063-203-90) 90 tablet2010-08-130000-00-00NoNoCurrent