lithium carbonate

FDA Drug Profile — LITHOBID, lithium carbonate, Lithium Carbonate

lithium carbonate is listed in the FDA National Drug Code directory with 10 NDC codes, marketed under brand names including LITHOBID, lithium carbonate, Lithium Carbonate. Available dosage forms: tablet, film coated, extended release, capsule, powder.

Drug Details

Generic Name
lithium carbonate
Brand Names
LITHOBID, lithium carbonate, Lithium Carbonate
Application Number
NDA018027
Sponsor
ANI Pharmaceuticals, Inc.
NDC Codes
10
Dosage Forms
TABLET, FILM COATED, EXTENDED RELEASE, CAPSULE, POWDER
Routes
ORAL
Active Ingredients
LITHIUM CARBONATE

Indications and Usage

1 INDICATIONS AND USAGE Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: • Treatment of acute manic and mixed episodes in patients 7 years and older [see Clinical Studies ( 14 )] • Maintenance treatment in patients 7 years and older [see Clinical Studies ( 14 )] Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: • Treatment of acute manic and mixed episodes in patients 7 years and older ( 1 ) • Maintenance treatment in patients 7 years and older ( 1 )