Lamotrigine
- Product NDC
- 55648-272
- 11-digit product format
- 556480272
- Labeler code
- 55648
- Product ID
- 55648-272_ddc5823c-ca8f-4f63-9d7b-d54c82798452
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lamotrigine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Wockhardt Limited
- Application
- ANDA202498
- Marketing category
- ANDA
- Marketing start
- 2012-11-29
- 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
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55648-272-01 | Lamotrigine | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 1 |
| 55648-272-02 | Lamotrigine | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 1 |
| 55648-272-04 | Lamotrigine | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | | 1 |
| 55648-272-04 | Lamotrigine | 10 in 1 CARTON | TABLET, EXTENDED RELEASE | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55648-272 | LAMOTRIGINE TABLET, EXTENDED RELEASE [WOCKHARDT LIMITED] | 1 | Legacy NDC, 4 package rows | 20130105_d3a8267b-979f-431d-baba-4ad3c5aa05e4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 55648-272-01 | 55648027201 | 30 in 1 BOTTLE | Historical |
| 55648-272-02 | 55648027202 | 500 in 1 BOTTLE | Historical |
| 55648-272-04 | 55648027204 | 10 in 1 BLISTER PACK | Historical |