NDC 70771-1518

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 ID70771-1518_717d1fe1-5c2b-4e10-a4ac-12aed4ed13d4
NDC70771-1518
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 Strength250 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 70771-1518-3

30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1518-3)
Marketing Start Date2020-05-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70771-1518-2 [70771151802]

Lamotrigine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207763
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-14

NDC 70771-1518-3 [70771151803]

Lamotrigine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207763
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-14

NDC 70771-1518-5 [70771151805]

Lamotrigine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207763
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-14

NDC 70771-1518-4 [70771151804]

Lamotrigine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207763
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-14

NDC 70771-1518-9 [70771151809]

Lamotrigine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207763
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-14

Drug Details

Active Ingredients

IngredientStrength
LAMOTRIGINE250 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
67877-165LamotrigineLamotrigine
67877-164LamotrigineLamotrigine
67877-166LamotrigineLamotrigine
67877-167LamotrigineLamotrigine
68084-319LamotrigineLamotrigine
68084-318LamotrigineLamotrigine
68084-810LamotrigineLamotrigine
68151-4249LamotrigineLamotrigine
68382-007LamotrigineLamotrigine
68382-008LamotrigineLamotrigine
68382-108LamotrigineLamotrigine
68382-009LamotrigineLamotrigine
68382-109LamotrigineLamotrigine
68382-011LamotrigineLamotrigine
68382-006LamotrigineLamotrigine
68382-010LamotrigineLamotrigine
68462-244LamotrigineLamotrigine
68462-246LamotrigineLamotrigine
68462-245LamotrigineLamotrigine
68462-229LamotrigineLamotrigine
68462-228LamotrigineLamotrigine
68462-243LamotrigineLamotrigine
68788-6868LamotrigineLamotrigine
68788-6822LAMOTRIGINELAMOTRIGINE
68788-7223LamotrigineLamotrigine
68788-7278LAMOTRIGINELAMOTRIGINE
68788-7168LamotrigineLamotrigine
68788-7178LAMOTRIGINELAMOTRIGINE
68788-9526LamotrigineLamotrigine
69097-151LAMOTRIGINELAMOTRIGINE
69097-149LAMOTRIGINELAMOTRIGINE
69097-152LAMOTRIGINELAMOTRIGINE
69097-148LAMOTRIGINELAMOTRIGINE
69102-639LAMOTRIGINELAMOTRIGINE
70518-0001LAMOTRIGINELAMOTRIGINE
70518-1153LamotrigineLamotrigine
70518-1479LamotrigineLamotrigine

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