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Lamotrigine - Medication Information

Product NDC Code 70771-1518
Drug Name

Lamotrigine

Type Brand
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 250 mg/1
Route ORAL
Dosage Form TABLET, EXTENDED RELEASE
RxCUI drug identifier 850087,
850091,
900156,
900164,
1098608,
1146690
Application Number ANDA207763
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
70771-1518-3 30 tablet, extended release in 1 bottle (70771-1518-3)
70771-1518-4 10 blister pack in 1 carton (70771-1518-4) / 10 tablet, extended release in 1 blister pack (70771-1518-2)
70771-1518-5 500 tablet, extended release in 1 bottle (70771-1518-5)
70771-1518-9 90 tablet, extended release in 1 bottle (70771-1518-9)
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Spl product data elements

Usually a list of ingredients in a drug product.
Lamotrigine Lamotirigine LAMOTRIGINE LAMOTRIGINE D&C YELLOW NO. 10 FERRIC OXIDE RED FERRIC OXIDE YELLOW GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TRIETHYL CITRATE TITANIUM DIOXIDE WATER LIGHT YELLOW TO YELLOW ROUND 979 Lamotrigine Lamotirigine LAMOTRIGINE LAMOTRIGINE D&C YELLOW NO. 10 FD&C BLUE NO. 2 FERRIC OXIDE YELLOW GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TRIETHYL CITRATE TITANIUM DIOXIDE WATER LIGHT GREEN TO GREEN ROUND 980 Lamotrigine Lamotirigine LAMOTRIGINE LAMOTRIGINE D&C YELLOW NO. 10 D&C RED NO. 27 FERRIC OXIDE YELLOW GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TRIETHYL CITRATE TITANIUM DIOXIDE WATER LIGHT ORANGE TO ORANGE ROUND 981 Lamotrigine Lamotirigine LAMOTRIGINE LAMOTRIGINE FD&C BLUE NO. 2 FERROSOFERRIC OXIDE GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TRIETHYL CITRATE TITANIUM DIOXIDE WATER LIGHT BLUE TO BLUE ROUND 982 Lamotrigine Lamotirigine LAMOTRIGINE LAMOTRIGINE FD&C BLUE NO. 2 FERROSOFERRIC OXIDE GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TRIETHYL CITRATE TITANIUM DIOXIDE WATER CARMINIC ACID LIGHT PURPLE TO PURPLE OVAL 983 Lamotrigine Lamotirigine LAMOTRIGINE LAMOTRIGINE FD&C BLUE NO. 2 FERROSOFERRIC OXIDE GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TRIETHYL CITRATE TITANIUM DIOXIDE WATER FERRIC OXIDE YELLOW LIGHT GRAY TO GRAY OVAL 984

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 NDC 70771-1514-3 Lamotrigine extended-release tablets, 25 mg Rx only 30 tablets NDC 70771-1515-3 Lamotrigine extended-release tablets, 50 mg Rx only 30 tablets NDC 70771-1516-3 Lamotrigine extended-release tablets, 100 mg Rx only 30 tablets NDC 70771-1517-3 Lamotrigine extended-release tablets, 200 mg Rx only 30 tablets NDC 70771-1518-3 Lamotrigine extended-release tablets, 250 mg Rx only 30 tablets NDC 70771-1519-3 Lamotrigine extended-release tablets, 300 mg Rx only 30 tablets 25 mg label 50 mg label 100 mg label 200 mg label 250 mg label 300 mg label

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