LAMOTRIGINE
- Product NDC
- 43063-202
- Requested package NDC
- 43063-202-30
- 11-digit product format
- 430630202
- Labeler code
- 43063
- Product ID
- 43063-202_dd408dab-1c46-d43f-e053-2995a90a7351
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LAMOTRIGINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078947
- Marketing category
- ANDA
- Marketing start
- 2009-01-27
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 43063-202 | 43063-202-30 | D | Discontinued by firm | 2026-08-03 |
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.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | 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#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | 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#
| 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… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43063-202-30 | EA - Each | 43063-202 | 7ab7fc08-4d16-4fcd-87a9-0cdcb04aea17 | 1 | 2012-07-24 |
| 43063-202-60 | EA - Each | 43063-202 | 648d9857-a125-4442-8d86-70269ef1c8ad | 1 | 2012-07-24 |
| 43063-202-90 | EA - Each | 43063-202 | 4964879e-d1c8-4eeb-9964-66e8677713e6 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LAMOTRIGINE | ACTIVE INGREDIENT | U3H27498KS | LAMOTRIGINE (LAMOTRIGINE ) TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| LAMOTRIGINE | ACTIVE MOIETY | U3H27498KS | LAMOTRIGINE (LAMOTRIGINE ) TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 |
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.
| 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 | 078947 ANDA078947 |
| LAMOTRIGINE | LAMOTRIGINE | Torrent Pharmaceuticals Limited | 3448839b-4933-4ef9-a80a-9e504d2c5696 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | 078947 ANDA078947 |
| LAMOTRIGINE | LAMOTRIGINE | REMEDYREPACK INC. | 50d46278-636a-470e-afcc-d3c8bd844e46 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 078947 ANDA078947 |
| LAMOTRIGINE | LAMOTRIGINE | PD-Rx Pharmaceuticals, Inc. | f31e1854-6068-4e45-b1e5-6def862fc466 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | 078947 ANDA078947 |
| LAMOTRIGINE | LAMOTRIGINE | PD-Rx Pharmaceuticals, Inc. | c638ab70-05dd-4f8b-9a11-b33a75f8c504 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | 078947 ANDA078947 |
| LAMOTRIGINE Kit | LAMOTRIGINE | OWP Pharmaceuticals, Inc. | 474fb321-575c-4b97-9dbe-080061652ee4 | 2026-03-27 | Boxed warning, Warnings, Adverse reactions | 078947 ANDA078947 |
| SUBVENITE | LAMOTRIGINE | OWP Pharmaceuticals, Inc. | 7ad18b68-ba16-4810-9c3e-27fa970454e8 | 2026-03-27 | Boxed warning, Warnings, Adverse reactions | 078947 ANDA078947 |
| LAMOTRIGINE | LAMOTRIGINE | Northwind Health Company, LLC | f7587283-781b-e111-e053-6394a90ad4cc | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 078947 ANDA078947 |
| LAMOTRIGINE | LAMOTRIGINE | NuCare Pharmaceuticals,Inc. | 1bbbe2a2-a9e8-8c13-e063-6394a90a9627 | 2024-06-25 | Boxed warning, Warnings, Adverse reactions | 078947 ANDA078947 |
| LAMOTRIGINE | LAMOTRIGINE | A-S Medication Solutions | 4e6cc1ad-55cd-4c7f-878c-fa6716e95897 | 2023-04-30 | Boxed warning, Warnings, Adverse reactions | 078947 ANDA078947 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43063-202-30 | 43063020230 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-202-30) | 30 tablet | 2010-08-12 | 0000-00-00 | No | No | Current |