LAMOTRIGINE
- Product NDC
- 69097-151
- 11-digit product format
- 690970151
- Labeler code
- 69097
- Product ID
- 69097-151_60f518f2-5321-454d-aef0-49b3b3f8a36d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA077783
- Marketing category
- ANDA
- Marketing start
- 2010-11-01
- Marketing end
- 0000-00-00
- Substance
- LAMOTRIGINE
- Active strength
- 150 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
- 2021-12-31
- 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69097-151-03 | EA - Each | 69097-151 | ad891a99-ef41-4220-94e7-a75d4e78005a | 1 | 2015-04-03 |
| 69097-151-12 | EA - Each | 69097-151 | bb144759-98c7-4778-bcae-51e22a487be3 | 1 | 2015-04-03 |
| 69097-151-15 | EA - Each | 69097-151 | 12c51e72-7715-41cd-87f9-a040c6d79cea | 1 | 2015-12-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LAMOTRIGINE | ACTIVE INGREDIENT | U3H27498KS | LAMOTRIGINE TABLET [CIPLA USA INC.] | 4 | |
| LAMOTRIGINE | ACTIVE MOIETY | U3H27498KS | LAMOTRIGINE TABLET [CIPLA USA INC.] | 4 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LAMOTRIGINE TABLET [CIPLA USA INC.] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | LAMOTRIGINE TABLET [CIPLA USA INC.] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LAMOTRIGINE TABLET [CIPLA USA INC.] | 4 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | LAMOTRIGINE TABLET [CIPLA USA INC.] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LAMOTRIGINE TABLET [CIPLA USA INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LAMOTRIGINE TABLET [CIPLA USA INC.] | 4 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | LAMOTRIGINE TABLET [CIPLA USA INC.] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | LAMOTRIGINE TABLET [CIPLA USA INC.] | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198428 | lamoTRIgine 150 MG Oral Tablet | PSN | 829e8675-959a-4fba-8e2b-464aaec930fa | 14 |
| 198428 | lamotrigine 150 MG Oral Tablet | SCD | 829e8675-959a-4fba-8e2b-464aaec930fa | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69097-151-02 | 69097015102 | 30 TABLET in 1 BOTTLE (69097-151-02) | 30 tablet | 2010-11-01 | 0000-00-00 | No | No | Current |
| 69097-151-03 | 69097015103 | 60 TABLET in 1 BOTTLE (69097-151-03) | 60 tablet | 2010-11-01 | 0000-00-00 | No | No | Current |
| 69097-151-12 | 69097015112 | 500 TABLET in 1 BOTTLE (69097-151-12) | 500 tablet | 2010-11-01 | 0000-00-00 | No | No | Current |
| 69097-151-15 | 69097015115 | 1000 TABLET in 1 BOTTLE (69097-151-15) | 1000 tablet | 2010-11-01 | 0000-00-00 | No | No | Current |