Lamotrigine Extended-release Tablets

Lamotrigine Extended-release Tablets
SPL v5
SPL
SPL Set ID ecb7a528-699f-4e51-9887-dee60456da2f
Route
ORAL
Published
Effective Date 2023-09-26
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lamotrigine (25 mg)
Inactive Ingredients
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 Fd&c Blue No. 2 D&c Red No. 27 Ferrosoferric Oxide Carminic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 984 Shape: round Shape: oval Color: yellow Color: green Color: orange Color: blue Color: purple Color: gray Size: 9 mm Size: 10 mm Size: 16 mm Score: 1
Marketing Status
ANDA Active Since 2020-05-14

Description

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


Medication Information

Description

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

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


Structured Label Content

Package Label.principal Display Panel (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)