Lamotrigine ER

Product NDC: 72189-467
11-digit product format: 721890467
Labeler code: 72189
Product ID: 72189-467_2c4ddaed-38a0-7cd7-e063-6294a90a148f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lamotrigine ER
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Direct_Rx
Application: ANDA207763
Marketing category: ANDA
Marketing start: 2023-05-03
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: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-467-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-467-30	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A207763-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01
A207763-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01
A207763-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01
A207763-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01
A207763-005	LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01
A207763-006	LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207763-001	AB
A207763-002	AB
A207763-003	AB
A207763-004	AB
A207763-005	AB
A207763-006	AB

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 6 · 240 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A207763-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207763-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207763-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207763-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207763-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207763-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207763-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207763-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207763-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207763-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207763-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207763-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207763-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207763-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207763-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207763-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207763-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207763-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207763-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207763-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207763-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207763-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207763-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207763-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207763-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207763-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207763-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207763-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207763-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207763-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207763-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207763-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207763-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207763-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207763-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207763-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207763-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207763-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207763-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207763-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-04-01	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 6 · 240 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207763-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207763-004	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207763-005	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207763-006	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207763-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207763-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207763-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207763-004	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207763-005	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207763-006	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207763-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207763-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207763-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207763-004	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207763-005	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207763-006	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207763-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207763-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207763-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207763-004	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207763-005	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207763-006	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207763-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207763-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207763-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207763-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207763-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207763-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207763-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207763-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207763-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207763-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207763-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207763-006	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207763-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207763-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207763-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207763-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207763-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207763-006	AB	1	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Lamotrigine ER
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LAMOTRIGINE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3H27498KS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
900156	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
faccacb7-65f1-cb00-e053-6394a90a9fcb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
14a9502b-3d70-0496-a7e1-b16edaa005b8	Product name	5	20250423
16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0	Product name	7	20250401
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-467-30	Lamotrigine ER	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-467-30	EA - Each	72189-467	6086aee5-678a-4e5b-a39b-3ba33436244e	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-467	LAMOTRIGINE ER TABLET, EXTENDED RELEASE [DIRECT_RX]	2	Current NDC, 1 package rows	20250123_faccacb7-65f1-cb00-e053-6394a90a9fcb.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lamotrigine	LAMOTRIGINE	REMEDYREPACK INC.	fa679e97-3b3d-4bf2-8de7-da3a89e38b37	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207763 application number: ANDA207763
Lamotrigine	LAMOTRIGINE	Zydus Pharmaceuticals USA Inc.	eb436371-d188-4803-a864-07b90c357e57	2025-11-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207763 application number: ANDA207763
Lamotrigine ER	LAMOTRIGINE ER	Direct_Rx	faccacb7-65f1-cb00-e053-6394a90a9fcb	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207763 application number: ANDA207763 ndc (product): 72189-467
Lamotrigine	LAMOTIRIGINE	Zydus Lifesciences Limited	ecb7a528-699f-4e51-9887-dee60456da2f	2024-11-30		Exact identifier application applno (ANDA): 207763 application number: ANDA207763

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3H27498KS	LAMOTRIGINE	84057-84-1	LAMOTRIGINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
900156	lamoTRIgine 200 MG 24HR Extended Release Oral Tablet	PSN	faccacb7-65f1-cb00-e053-6394a90a9fcb	2
900156	24 HR lamotrigine 200 MG Extended Release Oral Tablet	SCD	faccacb7-65f1-cb00-e053-6394a90a9fcb	2
900156	lamotrigine 200 MG 24 HR Extended Release Oral Tablet	SY	faccacb7-65f1-cb00-e053-6394a90a9fcb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72189-467-30	72189046730	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-467-30)	2023-05-03	No	No	Current