Lamotrigine
- Product NDC
- 55111-225
- 11-digit product format
- 551110225
- Labeler code
- 55111
- Product ID
- 55111-225_2cd813df-d72b-9337-d6ae-139b729a5e75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Dr.Reddy's Laboratories Limited
- Application
- ANDA076701
- Marketing category
- ANDA
- Marketing start
- 2009-01-29
- Substance
- LAMOTRIGINE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lamotrigine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LAMOTRIGINE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3H27498KS |
| Rxcui | 311264, 311265 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55111-225-01 | Lamotrigine | 100 in 1 BOTTLE | TABLET, CHEWABLE | 100 | | 9 |
| 55111-225-05 | Lamotrigine | 500 in 1 BOTTLE | TABLET, CHEWABLE | 500 | | 9 |
| 55111-225-30 | Lamotrigine | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | | 9 |
| 55111-225-60 | Lamotrigine | 60 in 1 BOTTLE | TABLET, CHEWABLE | 60 | | 9 |
| 55111-225-78 | Lamotrigine | 10 in 1 CARTON | TABLET, CHEWABLE | 10 | | 9 |
| 55111-225-79 | Lamotrigine | 10 in 1 BLISTER PACK | TABLET, CHEWABLE | 10 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| lamotrigine | ACTIVE INGREDIENT | U3H27498KS | LAMOTRIGINE TABLET, CHEWABLE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| lamotrigine | ACTIVE MOIETY | U3H27498KS | LAMOTRIGINE TABLET, CHEWABLE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| black currant | INACTIVE INGREDIENT | 9755T40D11 | LAMOTRIGINE TABLET, CHEWABLE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | LAMOTRIGINE TABLET, CHEWABLE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| crospovidone | INACTIVE INGREDIENT | 68401960MK | LAMOTRIGINE TABLET, CHEWABLE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | LAMOTRIGINE TABLET, CHEWABLE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | LAMOTRIGINE TABLET, CHEWABLE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| saccharin sodium dihydrate | INACTIVE INGREDIENT | SB8ZUX40TY | LAMOTRIGINE TABLET, CHEWABLE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LAMOTRIGINE TABLET, CHEWABLE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | LAMOTRIGINE TABLET, CHEWABLE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | LAMOTRIGINE TABLET, CHEWABLE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-225 | LAMOTRIGINE TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED] | 9 | Current NDC, Legacy NDC, 6 package rows | 20181211_e1a0da17-d67c-e44f-bd42-33c4009e4cdd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55111-225-01 | 55111022501 | 100 TABLET, CHEWABLE in 1 BOTTLE (55111-225-01) | | 2009-01-29 | 0000-00-00 | No | No | Current |
| 55111-225-05 | 55111022505 | 500 TABLET, CHEWABLE in 1 BOTTLE (55111-225-05) | | 2009-01-29 | 0000-00-00 | No | No | Current |
| 55111-225-30 | 55111022530 | 30 TABLET, CHEWABLE in 1 BOTTLE (55111-225-30) | | 2009-01-29 | 0000-00-00 | No | No | Current |
| 55111-225-60 | 55111022560 | 60 TABLET, CHEWABLE in 1 BOTTLE (55111-225-60) | | 2009-01-29 | 0000-00-00 | No | No | Current |
| 55111-225-78 | 55111022578 | 10 BLISTER PACK in 1 CARTON (55111-225-78) / 10 TABLET, CHEWABLE in 1 BLISTER PACK (55111-225-79) | 10 blister pack | 2009-01-29 | 0000-00-00 | No | No | Current |
| 55111-225-79 | 55111022579 | 10 in 1 BLISTER PACK | | | | | | Historical |