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| Product NDC Code | 70771-1519 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Lamotrigine |
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| 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] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||
| Dosage Form | TABLET, EXTENDED RELEASE | ||||||||||
| RxCUI drug identifier | 850087, 850091, 900156, 900164, 1098608, 1146690 |
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| Application Number | ANDA207763 | ||||||||||
| Labeler Name | Zydus Lifesciences Limited | ||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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