SUBVENITE

Product NDC: 69102-312
11-digit product format: 691020312
Labeler code: 69102
Product ID: 69102-312_15cf4680-04a8-421c-a475-cd753b58b604
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LAMOTRIGINE
Dosage form: KIT
Labeler: OWP Pharmaceuticals, Inc.
Application: ANDA078947
Marketing category: ANDA
Marketing start: 2018-04-14
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	69102-312		I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69102-312	69102-312-01	I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078947-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27
A078947-002	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27
A078947-003	LAMOTRIGINE	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27
A078947-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078947-001	AB
A078947-002	AB
A078947-003	AB
A078947-004	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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078947-001	LAMOTRIGINE	25MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078947-002	LAMOTRIGINE	100MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078947-003	LAMOTRIGINE	150MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078947-004	LAMOTRIGINE	200MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078947-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078947-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078947-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078947-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078947-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078947-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078947-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078947-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078947-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078947-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078947-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078947-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078947-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078947-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078947-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078947-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078947-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078947-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078947-004	AB	1	`d06236e962d9…`

Additional Listing Data#

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

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 · 14 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198427	Internal RxNorm lookup
198428	Internal RxNorm lookup
198429	Internal RxNorm lookup
282401	Internal RxNorm lookup
751139	Internal RxNorm lookup
751563	Internal RxNorm lookup
753451	Internal RxNorm lookup
2001506	Internal RxNorm lookup
2001508	Internal RxNorm lookup
2003796	Internal RxNorm lookup
2003797	Internal RxNorm lookup
2003798	Internal RxNorm lookup
2003799	Internal RxNorm lookup
2003801	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
7ad18b68-ba16-4810-9c3e-27fa970454e8	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-04-11	These highlights do not include all the information needed to use SUBVENITE safely and effectively. See full prescribing information for SUBVENITE. SUBVENITE (lamotrigine) tablets, for oral use Initial U.S. Approval: 1994
2024-04-11	These highlights do not include all the information needed to use SUBVENITE safely and effectively. See full prescribing information for SUBVENITE. SUBVENITE (lamotrigine) tablets, for oral use Initial U.S. Approval: 1994
2024-01-30	These highlights do not include all the information needed to use SUBVENITE safely and effectively. See full prescribing information for SUBVENITE. SUBVENITE (lamotrigine) tablets, for oral use Initial U.S. Approval: 1994
2024-01-30	These highlights do not include all the information needed to use SUBVENITE safely and effectively. See full prescribing information for SUBVENITE. SUBVENITE (lamotrigine) tablets, for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69102-312-01	SUBVENITE	14 in 1 PACKAGE, COMBINATION	KIT	14		15
69102-312-01	SUBVENITE	1 in 1 BLISTER PACK	KIT	1		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69102-312-01	EA - Each	69102-312	f9170fe8-73d7-4e6e-b2a1-b8b16961d021	1	2018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69102-312	SUBVENITE (LAMOTRIGINE) TABLET SUBVENITE (LAMOTRIGINE) KIT [OWP PHARMACEUTICALS, INC.]	12	Current NDC, Legacy NDC, 2 package rows	20250102_7ad18b68-ba16-4810-9c3e-27fa970454e8.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LAMOTRIGINE	LAMOTRIGINE	REMEDYREPACK INC.	1d7c2d52-a78e-4508-8853-ba306cdeeaba	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
LAMOTRIGINE	LAMOTRIGINE	Torrent Pharmaceuticals Limited	3448839b-4933-4ef9-a80a-9e504d2c5696	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
LAMOTRIGINE	LAMOTRIGINE	REMEDYREPACK INC.	50d46278-636a-470e-afcc-d3c8bd844e46	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
LAMOTRIGINE	LAMOTRIGINE	PD-Rx Pharmaceuticals, Inc.	f31e1854-6068-4e45-b1e5-6def862fc466	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
LAMOTRIGINE	LAMOTRIGINE	PD-Rx Pharmaceuticals, Inc.	c638ab70-05dd-4f8b-9a11-b33a75f8c504	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
LAMOTRIGINE Kit	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	474fb321-575c-4b97-9dbe-080061652ee4	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
SUBVENITE	LAMOTRIGINE	OWP Pharmaceuticals, Inc.	7ad18b68-ba16-4810-9c3e-27fa970454e8	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947 ndc (product): 69102-312
LAMOTRIGINE	LAMOTRIGINE	Northwind Health Company, LLC	f7587283-781b-e111-e053-6394a90ad4cc	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
LAMOTRIGINE	LAMOTRIGINE	NuCare Pharmaceuticals,Inc.	1bbbe2a2-a9e8-8c13-e063-6394a90a9627	2024-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947
LAMOTRIGINE	LAMOTRIGINE	A-S Medication Solutions	4e6cc1ad-55cd-4c7f-878c-fa6716e95897	2023-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078947 application number: ANDA078947

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
2003797	{14 (lamotrigine 100 MG Oral Tablet [Subvenite]) / 84 (lamotrigine 25 MG Oral Tablet [Subvenite]) } Pack [Subvenite Green (for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone and Not Taking Valproate)]	BPCK	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
2003799	{35 (lamotrigine 25 MG Oral Tablet [Subvenite]) } Pack [Subvenite Blue (for Patients Taking Valproate)]	BPCK	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
2003798	{7 (lamotrigine 100 MG Oral Tablet [Subvenite]) / 42 (lamotrigine 25 MG Oral Tablet [Subvenite]) } Pack [Subvenite Orange (for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate)]	BPCK	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
753451	{14 (lamotrigine 100 MG Oral Tablet) / 84 (lamotrigine 25 MG Oral Tablet) } Pack	GPCK	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
751139	{35 (lamotrigine 25 MG Oral Tablet) } Pack	GPCK	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
751563	{7 (lamotrigine 100 MG Oral Tablet) / 42 (lamotrigine 25 MG Oral Tablet) } Pack	GPCK	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
198427	lamoTRIgine 100 MG Oral Tablet	PSN	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
198428	lamoTRIgine 150 MG Oral Tablet	PSN	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
198429	lamoTRIgine 200 MG Oral Tablet	PSN	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
751563	lamoTRIgine 25 MG (42), 100 MG (7) Oral Tablet 49 Count Pack	PSN	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
753451	lamoTRIgine 25 MG (84), 100 MG (14) Oral Tablet 98 Count Pack	PSN	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
282401	lamoTRIgine 25 MG Oral Tablet	PSN	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
751139	lamoTRIgine 25 MG Oral Tablet 35 Count Pack	PSN	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
2003796	Subvenite 100 MG Oral Tablet	PSN	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
2001506	Subvenite 150 MG Oral Tablet	PSN	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
2003801	Subvenite 200 MG Oral Tablet	PSN	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
2001508	Subvenite 25 MG Oral Tablet	PSN	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
2003799	Subvenite Starter Kit Blue 25 MG 35 Count	PSN	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
2003797	Subvenite Starter Kit Green 25 MG (84), 100 MG (14) 98 Count	PSN	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
2003798	Subvenite Starter Kit Orange 25 MG (42), 100 MG (7) 49 Count	PSN	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
2003796	lamotrigine 100 MG Oral Tablet [Subvenite]	SBD	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
2001506	lamotrigine 150 MG Oral Tablet [Subvenite]	SBD	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
2003801	lamotrigine 200 MG Oral Tablet [Subvenite]	SBD	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
2001508	lamotrigine 25 MG Oral Tablet [Subvenite]	SBD	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
198427	lamotrigine 100 MG Oral Tablet	SCD	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
198428	lamotrigine 150 MG Oral Tablet	SCD	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
198429	lamotrigine 200 MG Oral Tablet	SCD	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
282401	lamotrigine 25 MG Oral Tablet	SCD	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
751139	lamotrigine Blue (For Patients Taking Valproate)	SY	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
753451	lamotrigine Green (For Patients Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Rifampin and Not Taking Valproate)	SY	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
751563	lamotrigine Orange (USP Starter Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate)	SY	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
2003796	Subvenite 100 MG Oral Tablet	SY	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
2001506	Subvenite 150 MG Oral Tablet	SY	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
2003801	Subvenite 200 MG Oral Tablet	SY	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
2001508	Subvenite 25 MG Oral Tablet	SY	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
2003799	Subvenite Blue Kit (for Patients Taking Valproate)	SY	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
2003797	Subvenite Green Kit (for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone and Not Taking Valproate)	SY	7ad18b68-ba16-4810-9c3e-27fa970454e8	15
2003798	Subvenite Orange Kit (for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate)	SY	7ad18b68-ba16-4810-9c3e-27fa970454e8	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69102-312-01	69102031201	14 BLISTER PACK in 1 PACKAGE, COMBINATION (69102-312-01) / 1 KIT in 1 BLISTER PACK	14 blister pack	2018-04-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SUBVENITE	OWP Pharmaceuticals, Inc. \| Torrent Pharmaceuticals Limited	2026-03-27	HUMAN PRESCRIPTION DRUG LABEL	15