FDA.reportPublic FDA data

Lamotrigine Extended Release

Product NDC
49884-561
11-digit product format
498840561
Labeler code
49884
Product ID
49884-561_9c5e0c2a-800e-47e9-a26b-582b98a05957
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamotrigine extended release
Dosage form
TABLET
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA201791
Marketing category
ANDA
Marketing start
2013-01-18
Marketing end
2026-09-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lamotrigine Extended Release

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMOTRIGINE25 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
49884-561-01Lamotrigine Extended Release100 in 1 BOTTLETABLET10021
49884-561-05Lamotrigine Extended Release500 in 1 BOTTLETABLET50021
49884-561-11Lamotrigine Extended Release30 in 1 BOTTLETABLET3021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-561-11EA - Each49884-5613dcd8ea7-3f91-45a1-beab-f877e7d271f012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LAMOTRIGINEACTIVE INGREDIENTU3H27498KSLAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.]7
LAMOTRIGINEACTIVE MOIETYU3H27498KSLAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.]7
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656LAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-561LAMOTRIGINE EXTENDED RELEASE TABLET [ENDO USA, INC.]15Current NDC, Legacy NDC, 3 package rows20240913_fb59c76a-9b6f-40ea-ac3a-58c3195c4377.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
850087lamoTRIgine 100 MG 24HR Extended Release Oral TabletPSNfb59c76a-9b6f-40ea-ac3a-58c3195c437721
900156lamoTRIgine 200 MG 24HR Extended Release Oral TabletPSNfb59c76a-9b6f-40ea-ac3a-58c3195c437721
900164lamoTRIgine 25 MG 24HR Extended Release Oral TabletPSNfb59c76a-9b6f-40ea-ac3a-58c3195c437721
1146690lamoTRIgine 250 MG 24HR Extended Release Oral TabletPSNfb59c76a-9b6f-40ea-ac3a-58c3195c437721
1098608lamoTRIgine 300 MG 24HR Extended Release Oral TabletPSNfb59c76a-9b6f-40ea-ac3a-58c3195c437721
850091lamoTRIgine 50 MG 24HR Extended Release Oral TabletPSNfb59c76a-9b6f-40ea-ac3a-58c3195c437721
85008724 HR lamotrigine 100 MG Extended Release Oral TabletSCDfb59c76a-9b6f-40ea-ac3a-58c3195c437721
90015624 HR lamotrigine 200 MG Extended Release Oral TabletSCDfb59c76a-9b6f-40ea-ac3a-58c3195c437721
90016424 HR lamotrigine 25 MG Extended Release Oral TabletSCDfb59c76a-9b6f-40ea-ac3a-58c3195c437721
114669024 HR lamotrigine 250 MG Extended Release Oral TabletSCDfb59c76a-9b6f-40ea-ac3a-58c3195c437721
109860824 HR lamotrigine 300 MG Extended Release Oral TabletSCDfb59c76a-9b6f-40ea-ac3a-58c3195c437721
85009124 HR lamotrigine 50 MG Extended Release Oral TabletSCDfb59c76a-9b6f-40ea-ac3a-58c3195c437721
850087lamotrigine 100 MG 24 HR Extended Release Oral TabletSYfb59c76a-9b6f-40ea-ac3a-58c3195c437721
900156lamotrigine 200 MG 24 HR Extended Release Oral TabletSYfb59c76a-9b6f-40ea-ac3a-58c3195c437721
900164lamotrigine 25 MG 24 HR Extended Release Oral TabletSYfb59c76a-9b6f-40ea-ac3a-58c3195c437721
1146690lamotrigine 250 MG 24 HR Extended Release Oral TabletSYfb59c76a-9b6f-40ea-ac3a-58c3195c437721
1098608lamotrigine 300 MG 24 HR Extended Release Oral TabletSYfb59c76a-9b6f-40ea-ac3a-58c3195c437721
850091lamotrigine 50 MG 24 HR Extended Release Oral TabletSYfb59c76a-9b6f-40ea-ac3a-58c3195c437721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-561-0149884056101100 TABLET in 1 BOTTLE (49884-561-01) 100 tablet2013-01-180000-00-00NoNoCurrent
49884-561-0549884056105500 TABLET in 1 BOTTLE (49884-561-05) 500 tablet2013-01-180000-00-00NoNoCurrent
49884-561-114988405611130 TABLET in 1 BOTTLE (49884-561-11) 30 tablet2013-01-182026-09-30NoNoCurrent