FDA.reportPublic FDA data

LAMOTRIGINE

Product NDC
13668-694
11-digit product format
136680694
Labeler code
13668
Product ID
13668-694_1a7c93f4-7ede-4574-b2f5-5d01dc87cdf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAMOTRIGINE
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA217100
Marketing category
ANDA
Marketing start
2026-01-08
Substance
LAMOTRIGINE
Active strength
50 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217100-001LAMOTRIGINELAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2026-01-08
A217100-002LAMOTRIGINELAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2026-01-08
A217100-003LAMOTRIGINELAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2026-01-08
A217100-004LAMOTRIGINELAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2026-01-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A217100-001AB
A217100-002AB
A217100-003AB
A217100-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217100-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2026-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217100-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2026-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217100-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2026-01-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217100-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2026-01-08011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217100-001LAMOTRIGINE25MGTABLET, ORALLY DISINTEGRATING / ORALAB2026-01-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217100-002LAMOTRIGINE50MGTABLET, ORALLY DISINTEGRATING / ORALAB2026-01-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217100-003LAMOTRIGINE100MGTABLET, ORALLY DISINTEGRATING / ORALAB2026-01-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217100-004LAMOTRIGINE200MGTABLET, ORALLY DISINTEGRATING / ORALAB2026-01-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217100-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217100-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217100-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217100-004AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217100-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217100-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217100-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217100-004AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMOTRIGINE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3H27498KSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
103968Internal RxNorm lookup
198430Internal RxNorm lookup
252478Internal RxNorm lookup
252479Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
22225cc4-028e-43ad-8e1f-dcebdc244ecbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
14a9502b-3d70-0496-a7e1-b16edaa005b8Product name520250423
16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0Product name720250401
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-694-01LAMOTRIGINE100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1005
13668-694-30LAMOTRIGINE30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING305
13668-694-71LAMOTRIGINE10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING105
13668-694-72LAMOTRIGINE30 in 1 CARTONTABLET, ORALLY DISINTEGRATING305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-694-30EA - Each13668-694670bd28b-72b9-45bf-9633-fb9f8dd3485b12026-04-20

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LAMOTRIGINELAMOTRIGINETorrent Pharmaceuticals Limited22225cc4-028e-43ad-8e1f-dcebdc244ecb2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217100
application number: ANDA217100
ndc (product): 13668-694

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103968lamoTRIgine 100 MG Disintegrating Oral TabletPSN22225cc4-028e-43ad-8e1f-dcebdc244ecb5
252479lamoTRIgine 200 MG Disintegrating Oral TabletPSN22225cc4-028e-43ad-8e1f-dcebdc244ecb5
198430lamoTRIgine 25 MG Disintegrating Oral TabletPSN22225cc4-028e-43ad-8e1f-dcebdc244ecb5
252478lamoTRIgine 50 MG Disintegrating Oral TabletPSN22225cc4-028e-43ad-8e1f-dcebdc244ecb5
103968lamotrigine 100 MG Disintegrating Oral TabletSCD22225cc4-028e-43ad-8e1f-dcebdc244ecb5
252479lamotrigine 200 MG Disintegrating Oral TabletSCD22225cc4-028e-43ad-8e1f-dcebdc244ecb5
198430lamotrigine 25 MG Disintegrating Oral TabletSCD22225cc4-028e-43ad-8e1f-dcebdc244ecb5
252478lamotrigine 50 MG Disintegrating Oral TabletSCD22225cc4-028e-43ad-8e1f-dcebdc244ecb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13668-694-0113668069401100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-694-01) 2026-01-08NoNoCurrent
13668-694-301366806943030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-694-30) 2026-01-08NoNoCurrent
13668-694-711366806947110 in 1 BLISTER PACKHistorical
13668-694-721366806947230 BLISTER PACK in 1 CARTON (13668-694-72) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (13668-694-71) 30 blister pack2026-01-08NoNoCurrent