Drugplain

Lithium carbonate 300 mg/1

Lithium carbonate · TABLET, FILM COATED, EXTENDED RELEASE · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

4 Recalls on Record
Plain English

Lithium carbonate is a mood-stabilizing medication used to treat bipolar disorder, particularly to reduce the severity and frequency of manic episodes. This extended-release tablet form is taken by mouth and requires regular monitoring to ensure safe and effective use.

Key Facts

Brand Name
Lithium carbonate
Generic Name
Lithium carbonate
NDC Code (Product)
23155-763
Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Strength
300 mg/1
Dosage Form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA205532
Marketing Start
10/20/2020

Recall History

4 Recalls on Record
Class II01/26/2022

CARDINAL HEALTHCARE

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 450 mg may be potentially mislabled as one of the following drugs: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD21790_19, EXP: 5/1/2014; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 MILLION CFU, NDC 43292050022, Pedigree: AD46257_28, EXP: 5/15/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W002729, EXP: 6

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg) may be potentially mislabled as one of the following drugs: CYCLOBENZAPRINE HCL, Tablet, 5 mg, NDC 00591325601, Pedigree: AD73525_7, EXP: 5/30/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD21846_11, EXP: 5/1/2014.

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 300 mg may be potentially mislabled as the following drug: VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg, NDC 40985022251, Pedigree: AD39588_10, EXP: 5/13/2014.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is Lithium carbonate used for?

Lithium carbonate is a mood-stabilizing medication used to treat bipolar disorder, particularly to reduce the severity and frequency of manic episodes. This extended-release tablet form is taken by mouth and requires regular monitoring to ensure safe and effective use.

Is Lithium carbonate a controlled substance?

Lithium carbonate is not classified as a controlled substance by the DEA.

What is the generic name for Lithium carbonate?

The generic name for Lithium carbonate is Lithium carbonate. There are 11 other brand versions of Lithium carbonate.

What is the NDC code for Lithium carbonate 300 mg/1?

The NDC (National Drug Code) for Lithium carbonate 300 mg/1 is 23155-763, listed by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc..