Lamotrigine Extended Release
- Product NDC
- 49884-564
- 11-digit product format
- 498840564
- Labeler code
- 49884
- Product ID
- 49884-564_3c26caa3-84f9-442d-b752-9dda35d0bacb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lamotrigine extended release
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Par Pharmaceutical, Inc.
- Application
- ANDA201791
- Marketing category
- ANDA
- Marketing start
- 2013-01-18
- Marketing end
- 0000-00-00
- Substance
- LAMOTRIGINE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|---|---|---|---|---|---|
| 49884-564-01 | Lamotrigine Extended Release | 100 in 1 BOTTLE | TABLET | 100 | 21 | |
| 49884-564-05 | Lamotrigine Extended Release | 500 in 1 BOTTLE | TABLET | 500 | 21 | |
| 49884-564-11 | Lamotrigine Extended Release | 30 in 1 BOTTLE | TABLET | 30 | 21 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49884-564-11 | EA - Each | 49884-564 | f9ebbe2b-baf2-42f6-a7cc-0641cb5aac82 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LAMOTRIGINE | ACTIVE INGREDIENT | U3H27498KS | LAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.] | 7 | |
| LAMOTRIGINE | ACTIVE MOIETY | U3H27498KS | LAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.] | 7 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | LAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.] | 7 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.] | 7 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | LAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.] | 7 | |
| METHACRYLIC ACID | INACTIVE INGREDIENT | 1CS02G8656 | LAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.] | 7 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.] | 7 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 850087 | lamoTRIgine 100 MG 24HR Extended Release Oral Tablet | PSN | fb59c76a-9b6f-40ea-ac3a-58c3195c4377 | 21 |
| 900156 | lamoTRIgine 200 MG 24HR Extended Release Oral Tablet | PSN | fb59c76a-9b6f-40ea-ac3a-58c3195c4377 | 21 |
| 900164 | lamoTRIgine 25 MG 24HR Extended Release Oral Tablet | PSN | fb59c76a-9b6f-40ea-ac3a-58c3195c4377 | 21 |
| 1146690 | lamoTRIgine 250 MG 24HR Extended Release Oral Tablet | PSN | fb59c76a-9b6f-40ea-ac3a-58c3195c4377 | 21 |
| 1098608 | lamoTRIgine 300 MG 24HR Extended Release Oral Tablet | PSN | fb59c76a-9b6f-40ea-ac3a-58c3195c4377 | 21 |
| 850091 | lamoTRIgine 50 MG 24HR Extended Release Oral Tablet | PSN | fb59c76a-9b6f-40ea-ac3a-58c3195c4377 | 21 |
| 850087 | 24 HR lamotrigine 100 MG Extended Release Oral Tablet | SCD | fb59c76a-9b6f-40ea-ac3a-58c3195c4377 | 21 |
| 900156 | 24 HR lamotrigine 200 MG Extended Release Oral Tablet | SCD | fb59c76a-9b6f-40ea-ac3a-58c3195c4377 | 21 |
| 900164 | 24 HR lamotrigine 25 MG Extended Release Oral Tablet | SCD | fb59c76a-9b6f-40ea-ac3a-58c3195c4377 | 21 |
| 1146690 | 24 HR lamotrigine 250 MG Extended Release Oral Tablet | SCD | fb59c76a-9b6f-40ea-ac3a-58c3195c4377 | 21 |
| 1098608 | 24 HR lamotrigine 300 MG Extended Release Oral Tablet | SCD | fb59c76a-9b6f-40ea-ac3a-58c3195c4377 | 21 |
| 850091 | 24 HR lamotrigine 50 MG Extended Release Oral Tablet | SCD | fb59c76a-9b6f-40ea-ac3a-58c3195c4377 | 21 |
| 850087 | lamotrigine 100 MG 24 HR Extended Release Oral Tablet | SY | fb59c76a-9b6f-40ea-ac3a-58c3195c4377 | 21 |
| 900156 | lamotrigine 200 MG 24 HR Extended Release Oral Tablet | SY | fb59c76a-9b6f-40ea-ac3a-58c3195c4377 | 21 |
| 900164 | lamotrigine 25 MG 24 HR Extended Release Oral Tablet | SY | fb59c76a-9b6f-40ea-ac3a-58c3195c4377 | 21 |
| 1146690 | lamotrigine 250 MG 24 HR Extended Release Oral Tablet | SY | fb59c76a-9b6f-40ea-ac3a-58c3195c4377 | 21 |
| 1098608 | lamotrigine 300 MG 24 HR Extended Release Oral Tablet | SY | fb59c76a-9b6f-40ea-ac3a-58c3195c4377 | 21 |
| 850091 | lamotrigine 50 MG 24 HR Extended Release Oral Tablet | SY | fb59c76a-9b6f-40ea-ac3a-58c3195c4377 | 21 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49884-564-01 | 49884056401 | 100 TABLET in 1 BOTTLE (49884-564-01) | 100 tablet | 2013-01-18 | 0000-00-00 | No | No | Current |
| 49884-564-05 | 49884056405 | 500 TABLET in 1 BOTTLE (49884-564-05) | 500 tablet | 2013-01-18 | 0000-00-00 | No | No | Current |
| 49884-564-11 | 49884056411 | 30 TABLET in 1 BOTTLE (49884-564-11) | 30 tablet | 2013-01-18 | 0000-00-00 | No | No | Current |