NDC 70771-1514

Lamotrigine

Lamotirigine

Lamotrigine is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Cadila Healthcare Limited. The primary component is Lamotrigine.

Product ID70771-1514_717d1fe1-5c2b-4e10-a4ac-12aed4ed13d4
NDC70771-1514
Product TypeHuman Prescription Drug
Proprietary NameLamotrigine
Generic NameLamotirigine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2020-05-14
Marketing CategoryANDA / ANDA
Application NumberANDA207763
Labeler NameCadila Healthcare Limited
Substance NameLAMOTRIGINE
Active Ingredient Strength25 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 70771-1514-3

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1514-3)
Marketing Start Date2020-05-14
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
LAMOTRIGINE25 mg/1

OpenFDA Data

SPL SET ID:ecb7a528-699f-4e51-9887-dee60456da2f
Manufacturer
UNII

NDC Crossover Matching brand name "Lamotrigine" or generic name "Lamotirigine"

NDCBrand NameGeneric Name
0093-0039LamotrigineLamotrigine
0093-0132LamotrigineLamotrigine
0093-0463LamotrigineLamotrigine
0093-0688LamotrigineLamotrigine
0093-7247LamotrigineLamotrigine
0093-7248LamotrigineLamotrigine
0115-1526LamotrigineLAMOTRIGINE
0115-1527LamotrigineLAMOTRIGINE
0115-1528LamotrigineLAMOTRIGINE
0115-1529LamotrigineLAMOTRIGINE
0115-9939LamotrigineLAMOTRIGINE
0115-9940LamotrigineLAMOTRIGINE
0115-9941LamotrigineLAMOTRIGINE
0115-9942LamotrigineLAMOTRIGINE
0143-9964LamotrigineLamotrigine
0143-9965LamotrigineLamotrigine
0143-9966LamotrigineLamotrigine
0143-9967LamotrigineLamotrigine
0228-1410LamotrigineLamotrigine
0228-1422LamotrigineLamotrigine
0228-1435LamotrigineLamotrigine
0228-1453LamotrigineLamotrigine
0228-1580LamotrigineLamotrigine
0228-1638LamotrigineLamotrigine
0378-4251Lamotriginelamotrigine
0378-4252Lamotriginelamotrigine
0378-4253Lamotriginelamotrigine
0378-4254Lamotriginelamotrigine
0615-7544LamotrigineLamotrigine
0615-7545LamotrigineLamotrigine
0615-7546LamotrigineLamotrigine
0615-7547LamotrigineLamotrigine
0615-7964LamotrigineLamotrigine
0615-7975LamotrigineLamotrigine
0615-8150LamotrigineLamotrigine
0615-8267lamotriginelamotrigine
0781-4040LamotrigineLamotrigine
0781-5122LamotrigineLamotrigine
0781-5123LamotrigineLamotrigine
0781-5124LamotrigineLamotrigine
0781-5125LamotrigineLamotrigine
13668-045LAMOTRIGINELAMOTRIGINE
13668-047LAMOTRIGINELAMOTRIGINE
13668-048LAMOTRIGINELAMOTRIGINE
13668-049LAMOTRIGINELAMOTRIGINE
13668-266LAMOTRIGINElamotrigine
13668-339LamotrigineLamotrigine
13668-340LamotrigineLamotrigine
13668-341LamotrigineLamotrigine
13668-342LamotrigineLamotrigine

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.