lamotrigine
- Product NDC
- 31722-241
- 11-digit product format
- 317220241
- Labeler code
- 31722
- Product ID
- 31722-241_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
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- lamotrigine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LAMOTRIGINE | 50 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | U3H27498KS |
| Rxcui | 850087, 850091, 900156, 900164, 1098608, 1146690 |
DailyMed Product Concepts#
| 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 31722-241-30 | lamotrigine | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 31722-241-30 | EA - Each | 31722-241 | eace826c-d829-48af-87ac-f03d98767237 | 1 | 2022-12-07 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 850087 | lamoTRIgine 100 MG 24HR Extended Release Oral Tablet | PSN | e45bd69f-3580-ff15-e053-2a95a90a4615 | 7 |
| 900156 | lamoTRIgine 200 MG 24HR Extended Release Oral Tablet | PSN | e45bd69f-3580-ff15-e053-2a95a90a4615 | 7 |
| 900164 | lamoTRIgine 25 MG 24HR Extended Release Oral Tablet | PSN | e45bd69f-3580-ff15-e053-2a95a90a4615 | 7 |
| 1146690 | lamoTRIgine 250 MG 24HR Extended Release Oral Tablet | PSN | e45bd69f-3580-ff15-e053-2a95a90a4615 | 7 |
| 1098608 | lamoTRIgine 300 MG 24HR Extended Release Oral Tablet | PSN | e45bd69f-3580-ff15-e053-2a95a90a4615 | 7 |
| 850091 | lamoTRIgine 50 MG 24HR Extended Release Oral Tablet | PSN | e45bd69f-3580-ff15-e053-2a95a90a4615 | 7 |
| 850087 | 24 HR lamotrigine 100 MG Extended Release Oral Tablet | SCD | e45bd69f-3580-ff15-e053-2a95a90a4615 | 7 |
| 900156 | 24 HR lamotrigine 200 MG Extended Release Oral Tablet | SCD | e45bd69f-3580-ff15-e053-2a95a90a4615 | 7 |
| 900164 | 24 HR lamotrigine 25 MG Extended Release Oral Tablet | SCD | e45bd69f-3580-ff15-e053-2a95a90a4615 | 7 |
| 1146690 | 24 HR lamotrigine 250 MG Extended Release Oral Tablet | SCD | e45bd69f-3580-ff15-e053-2a95a90a4615 | 7 |
| 1098608 | 24 HR lamotrigine 300 MG Extended Release Oral Tablet | SCD | e45bd69f-3580-ff15-e053-2a95a90a4615 | 7 |
| 850091 | 24 HR lamotrigine 50 MG Extended Release Oral Tablet | SCD | e45bd69f-3580-ff15-e053-2a95a90a4615 | 7 |
| 850087 | lamotrigine 100 MG 24 HR Extended Release Oral Tablet | SY | e45bd69f-3580-ff15-e053-2a95a90a4615 | 7 |
| 900156 | lamotrigine 200 MG 24 HR Extended Release Oral Tablet | SY | e45bd69f-3580-ff15-e053-2a95a90a4615 | 7 |
| 900164 | lamotrigine 25 MG 24 HR Extended Release Oral Tablet | SY | e45bd69f-3580-ff15-e053-2a95a90a4615 | 7 |
| 1146690 | lamotrigine 250 MG 24 HR Extended Release Oral Tablet | SY | e45bd69f-3580-ff15-e053-2a95a90a4615 | 7 |
| 1098608 | lamotrigine 300 MG 24 HR Extended Release Oral Tablet | SY | e45bd69f-3580-ff15-e053-2a95a90a4615 | 7 |
| 850091 | lamotrigine 50 MG 24 HR Extended Release Oral Tablet | SY | e45bd69f-3580-ff15-e053-2a95a90a4615 | 7 |
| 850091 | lamoTRIgine 50 MG 24HR Extended Release Oral Tablet | PSN | 70ae07a2-2f5c-4b3f-b8c7-1ac8b83c0593 | 1 |
| 850091 | lamoTRIgine 50 MG 24HR Extended Release Oral Tablet | PSN | 39efe933-bfed-4a6a-b270-0883871c5186 | 1 |
| 850091 | 24 HR lamotrigine 50 MG Extended Release Oral Tablet | SCD | 70ae07a2-2f5c-4b3f-b8c7-1ac8b83c0593 | 1 |
| 850091 | 24 HR lamotrigine 50 MG Extended Release Oral Tablet | SCD | 39efe933-bfed-4a6a-b270-0883871c5186 | 1 |
| 850091 | lamotrigine 50 MG 24 HR Extended Release Oral Tablet | SY | 70ae07a2-2f5c-4b3f-b8c7-1ac8b83c0593 | 1 |
| 850091 | lamotrigine 50 MG 24 HR Extended Release Oral Tablet | SY | 39efe933-bfed-4a6a-b270-0883871c5186 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 31722-241-30 | 31722024130 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-241-30) | 2021-12-09 | 0000-00-00 | No | No | Current |