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Lamotrigine - Medication Information

Product NDC Code 65841-690
Drug Name

Lamotrigine

Type Generic
Pharm Class Anti-epileptic Agent [EPC],
Decreased Central Nervous System Disorganized Electrical Activity [PE],
Dihydrofolate Reductase Inhibitors [MoA],
Mood Stabilizer [EPC],
Organic Cation Transporter 2 Inhibitors [MoA]
Active Ingredients
Lamotrigine 25 mg/1
Route ORAL
Dosage Form TABLET, CHEWABLE
RxCUI drug identifier 198427,
198428,
198429,
199322,
249329,
282401,
311264,
311265
Application Number ANDA078009
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
65841-690-01 100 tablet, chewable in 1 bottle (65841-690-01)
65841-690-05 500 tablet, chewable in 1 bottle (65841-690-05)
65841-690-16 90 tablet, chewable in 1 bottle (65841-690-16)
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Spl product data elements

Usually a list of ingredients in a drug product.
Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF- WHITE ROUND ZC;79 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF- WHITE ROUND ZC;90 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF- WHITE ROUND ZC;80 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF- WHITE ROUND ZC;81 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF- WHITE ROUND ZC;82 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF- WHITE ROUND ZC;91 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MANNITOL TRIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE BLACK CURRANT WHITE TO OFF- WHITE Black Current ROUND Z;13 Lamotrigine Lamotrigine LAMOTRIGINE LAMOTRIGINE ASPARTAME CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MANNITOL TRIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE BLACK CURRANT WHITE TO OFF- WHITE Black Current ROUND Z;12

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Lamotrigine Tablets (Chewable, Dispersible), 5 mg NDC 65841-689-01 in bottle of 100 tablets 100 tablets Rx only Lamotrigine Tablets (Chewable, Dispersible), 5 mg Lamotrigine Tablets (Chewable, Dispersible), 25 mg NDC 65841-690-01 in bottle of 100 tablets 100 tablets Rx only Lamotrigine Tablets (Chewable, Dispersible), 25 mg Lamotrigine Tablets USP, 25 mg NDC 65841-682-01 in bottle of 100 tablets 100 tablets Rx only Lamotrigine Tablets USP, 25 mg Lamotrigine Tablets USP, 50 mg NDC 65841-683-01 in bottle of 100 tablets 100 tablets Rx only Lamotrigine Tablets USP, 50 mg Lamotrigine Tablets USP, 100 mg NDC 65841-684-01 in bottle of 100 tablets 100 tablets Rx only Lamotrigine Tablets USP, 100 mg Lamotrigine Tablets USP, 150 mg NDC 65841-685-14 in bottle of 60 tablets 60 tablets Rx only Lamotrigine Tablets USP, 150 mg Lamotrigine Tablets USP, 200 mg NDC 65841-686-14 in bottle of 60 tablets 60 tablets Rx only Lamotrigine Tablets USP, 200 mg Lamotrigine Tablets USP, 250 mg NDC 65841-687-05 in bottle of 500 tablets 500 tablets Rx only Lamotrigine Tablets USP, 250 mg Lamotrigine Tablets (Chewable, Dispersible), 5 mg Lamotrigine Tablets (Chewable, Dispersible), 5mg Lamotrigine Tablets (Chewable, Dispersible), 25 mg Lamotrigine Tablets USP, 25 mg Lamotrigine Tablets USP, 50 mg Lamotrigine Tablets USP, 100 mg Lamotrigine Tablets USP, 150 mg Lamotrigine Tablets USP, 200 mg Lamotrigine Tablets USP, 250 mg

Spl medguide

Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.
SPL MEDGUIDE

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API