lamotrigine

Product NDC
31722-243
11-digit product format
317220243
Labeler code
31722
Product ID
31722-243_49d44873-5b65-b8c2-e063-6294a90aa196
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lamotrigine extended-release
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals Inc
Application
ANDA213949
Marketing category
ANDA
Marketing start
2021-12-09
Substance
LAMOTRIGINE
Active strength
200 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213949-001LAMOTRIGINELAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08
A213949-002LAMOTRIGINELAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08
A213949-003LAMOTRIGINELAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08
A213949-004LAMOTRIGINELAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08
A213949-005LAMOTRIGINELAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08
A213949-006LAMOTRIGINELAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A213949-001AB
A213949-002AB
A213949-003AB
A213949-004AB
A213949-005AB
A213949-006AB

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.

Product history page 1 of 5 · 198 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213949-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213949-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213949-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213949-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213949-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213949-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213949-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2021-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213949-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2021-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213949-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2021-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213949-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2021-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213949-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2021-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213949-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2021-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A213949-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2021-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213949-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2021-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213949-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2021-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213949-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2021-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213949-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2021-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213949-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2021-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213949-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213949-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213949-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213949-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213949-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213949-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213949-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213949-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213949-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213949-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213949-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213949-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2021-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213949-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2021-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213949-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2021-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213949-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2021-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213949-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2021-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213949-005LAMOTRIGINE250MGTABLET, EXTENDED RELEASE / ORALAB2021-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213949-006LAMOTRIGINE300MGTABLET, EXTENDED RELEASE / ORALAB2021-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213949-001LAMOTRIGINE25MGTABLET, EXTENDED RELEASE / ORALAB2021-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213949-002LAMOTRIGINE50MGTABLET, EXTENDED RELEASE / ORALAB2021-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213949-003LAMOTRIGINE100MGTABLET, EXTENDED RELEASE / ORALAB2021-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213949-004LAMOTRIGINE200MGTABLET, EXTENDED RELEASE / ORALAB2021-12-082680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 198 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213949-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213949-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213949-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213949-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213949-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213949-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213949-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213949-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213949-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213949-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213949-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213949-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213949-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213949-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213949-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213949-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213949-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213949-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213949-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213949-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213949-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213949-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213949-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213949-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213949-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213949-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213949-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213949-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213949-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213949-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213949-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213949-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213949-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213949-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213949-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213949-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213949-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213949-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213949-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213949-004AB12680178bc6a6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMOTRIGINE200 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
850087Internal RxNorm lookup
850091Internal RxNorm lookup
900156Internal RxNorm lookup
900164Internal RxNorm lookup
1098608Internal RxNorm lookup
1146690Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e45bd69f-3580-ff15-e053-2a95a90a4615Available 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
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-243-30lamotrigine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-243-30EA - Each31722-243fad6e36d-b575-4928-b458-62d8fef1146a12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-243LAMOTRIGINE (LAMOTRIGINE EXTENDED-RELEASE) TABLET, FILM COATED, EXTENDED RELEASE [CAMBER PHARMACEUTICALS INC]5Current NDC, Legacy NDC, 1 package rows20250101_e45bd69f-3580-ff15-e053-2a95a90a4615.zip

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
lamotrigineLAMOTRIGINE EXTENDED-RELEASEREMEDYREPACK INC.65748114-c59c-4ebb-977e-d4aab5764dd32026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213949
application number: ANDA213949
lamotrigineLAMOTRIGINE EXTENDED-RELEASECamber Pharmaceuticals Ince45bd69f-3580-ff15-e053-2a95a90a46152026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213949
application number: ANDA213949
ndc (product): 31722-243
lamotrigineLAMOTRIGINE EXTENDED-RELEASEYiling Pharmaceutical, Inc.f7de11a5-5357-4753-b1ac-b15123b500282025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213949
application number: ANDA213949
lamotrigineLAMOTRIGINE EXTENDED-RELEASEREMEDYREPACK INC.70ae07a2-2f5c-4b3f-b8c7-1ac8b83c05932025-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213949
application number: ANDA213949
Lamotrigine ERLAMOTRIGINE ERDirect_rx1b42a7cf-86d8-e506-e063-6394a90a3c9b2024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213949
application number: ANDA213949
lamotrigineLAMOTRIGINE EXTENDED-RELEASEProficient Rx LP39efe933-bfed-4a6a-b270-0883871c51862023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213949
application number: ANDA213949

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
850087lamoTRIgine 100 MG 24HR Extended Release Oral TabletPSNe45bd69f-3580-ff15-e053-2a95a90a46157
900156lamoTRIgine 200 MG 24HR Extended Release Oral TabletPSNe45bd69f-3580-ff15-e053-2a95a90a46157
900164lamoTRIgine 25 MG 24HR Extended Release Oral TabletPSNe45bd69f-3580-ff15-e053-2a95a90a46157
1146690lamoTRIgine 250 MG 24HR Extended Release Oral TabletPSNe45bd69f-3580-ff15-e053-2a95a90a46157
1098608lamoTRIgine 300 MG 24HR Extended Release Oral TabletPSNe45bd69f-3580-ff15-e053-2a95a90a46157
850091lamoTRIgine 50 MG 24HR Extended Release Oral TabletPSNe45bd69f-3580-ff15-e053-2a95a90a46157
85008724 HR lamotrigine 100 MG Extended Release Oral TabletSCDe45bd69f-3580-ff15-e053-2a95a90a46157
90015624 HR lamotrigine 200 MG Extended Release Oral TabletSCDe45bd69f-3580-ff15-e053-2a95a90a46157
90016424 HR lamotrigine 25 MG Extended Release Oral TabletSCDe45bd69f-3580-ff15-e053-2a95a90a46157
114669024 HR lamotrigine 250 MG Extended Release Oral TabletSCDe45bd69f-3580-ff15-e053-2a95a90a46157
109860824 HR lamotrigine 300 MG Extended Release Oral TabletSCDe45bd69f-3580-ff15-e053-2a95a90a46157
85009124 HR lamotrigine 50 MG Extended Release Oral TabletSCDe45bd69f-3580-ff15-e053-2a95a90a46157
850087lamotrigine 100 MG 24 HR Extended Release Oral TabletSYe45bd69f-3580-ff15-e053-2a95a90a46157
900156lamotrigine 200 MG 24 HR Extended Release Oral TabletSYe45bd69f-3580-ff15-e053-2a95a90a46157
900164lamotrigine 25 MG 24 HR Extended Release Oral TabletSYe45bd69f-3580-ff15-e053-2a95a90a46157
1146690lamotrigine 250 MG 24 HR Extended Release Oral TabletSYe45bd69f-3580-ff15-e053-2a95a90a46157
1098608lamotrigine 300 MG 24 HR Extended Release Oral TabletSYe45bd69f-3580-ff15-e053-2a95a90a46157
850091lamotrigine 50 MG 24 HR Extended Release Oral TabletSYe45bd69f-3580-ff15-e053-2a95a90a46157
900156lamoTRIgine 200 MG 24HR Extended Release Oral TabletPSN65748114-c59c-4ebb-977e-d4aab5764dd31
900156lamoTRIgine 200 MG 24HR Extended Release Oral TabletPSN1b42a7cf-86d8-e506-e063-6394a90a3c9b1
90015624 HR lamotrigine 200 MG Extended Release Oral TabletSCD65748114-c59c-4ebb-977e-d4aab5764dd31
90015624 HR lamotrigine 200 MG Extended Release Oral TabletSCD1b42a7cf-86d8-e506-e063-6394a90a3c9b1
900156lamotrigine 200 MG 24 HR Extended Release Oral TabletSY65748114-c59c-4ebb-977e-d4aab5764dd31
900156lamotrigine 200 MG 24 HR Extended Release Oral TabletSY1b42a7cf-86d8-e506-e063-6394a90a3c9b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-243-303172202433030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-243-30) 2021-12-090000-00-00NoNoCurrent