Lamotrigine Tablet, Extended Release
FDA Label NDC 70771-1518

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Lamotrigine (NDC 70771-1518). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package Label.Principal Display Panel

NDC 70771-1514-3

Lamotrigine extended-release tablets, 25 mg

Rx only

30 tablets

25 mg Label (717d1fe1 5c2b 4e10 A4ac 12aed4ed13d4 01)

25 mg Label (717d1fe1 5c2b 4e10 A4ac 12aed4ed13d4 01)

NDC 70771-1515-3

Lamotrigine extended-release tablets, 50 mg

Rx only

30 tablets

50 mg Label (717d1fe1 5c2b 4e10 A4ac 12aed4ed13d4 02)

50 mg Label (717d1fe1 5c2b 4e10 A4ac 12aed4ed13d4 02)

NDC 70771-1516-3

Lamotrigine extended-release tablets, 100 mg

Rx only

30 tablets

100 mg Label (717d1fe1 5c2b 4e10 A4ac 12aed4ed13d4 03)

100 mg Label (717d1fe1 5c2b 4e10 A4ac 12aed4ed13d4 03)

NDC 70771-1517-3

Lamotrigine extended-release tablets, 200 mg

Rx only

30 tablets

200 mg Label (717d1fe1 5c2b 4e10 A4ac 12aed4ed13d4 04)

200 mg Label (717d1fe1 5c2b 4e10 A4ac 12aed4ed13d4 04)

NDC 70771-1518-3

Lamotrigine extended-release tablets, 250 mg

Rx only

30 tablets

250 mg Label (717d1fe1 5c2b 4e10 A4ac 12aed4ed13d4 05)

250 mg Label (717d1fe1 5c2b 4e10 A4ac 12aed4ed13d4 05)

NDC 70771-1519-3

Lamotrigine extended-release tablets, 300 mg

Rx only

30 tablets

300 mg Label (717d1fe1 5c2b 4e10 A4ac 12aed4ed13d4 06)

300 mg Label (717d1fe1 5c2b 4e10 A4ac 12aed4ed13d4 06)

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