FDA.reportPublic FDA data

LITHOBID

Product NDC
62559-280
11-digit product format
625590280
Labeler code
62559
Product ID
62559-280_75db0302-4a60-4b41-85fa-99ff2761ce56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lithium carbonate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
NDA018027
Marketing category
NDA
Marketing start
2014-07-01
Substance
LITHIUM CARBONATE
Active strength
300 mg/1
Pharmacologic classes
Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LITHOBID
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LITHIUM CARBONATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2BMD2GNA4V
Rxcui197891, 206786

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-280-01LITHOBID100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-280-01EA - Each62559-28021a0c71d-da62-43a8-8600-ad1f5086d74d12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
lithium carbonateACTIVE INGREDIENT2BMD2GNA4VLITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]1
Lithium cationACTIVE MOIETY8H8Z5UER66LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]1
calcium stearateINACTIVE INGREDIENT776XM7047LLITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZLITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKLITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOALITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]1
Hypromellose 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NLITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ELITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XLITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JLITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]1
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]1
sorbitolINACTIVE INGREDIENT506T60A25RLITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-280LITHOBID (LITHIUM CARBONATE) TABLET, FILM COATED, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 1 package rows20221029_f7f5b69a-c2a1-4586-a189-1475d41387c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197891lithium carbonate 300 MG Extended Release Oral TabletPSNf7f5b69a-c2a1-4586-a189-1475d41387c012
206786LITHOBID 300 MG Extended Release Oral TabletPSNf7f5b69a-c2a1-4586-a189-1475d41387c012
206786lithium carbonate 300 MG Extended Release Oral Tablet [Lithobid]SBDf7f5b69a-c2a1-4586-a189-1475d41387c012
197891lithium carbonate 300 MG Extended Release Oral TabletSCDf7f5b69a-c2a1-4586-a189-1475d41387c012
197891LiCO3 300 MG Extended Release Oral TabletSYf7f5b69a-c2a1-4586-a189-1475d41387c012
206786LiCO3 300 MG Extended Release Oral Tablet [Lithobid]SYf7f5b69a-c2a1-4586-a189-1475d41387c012
206786Lithobid 300 MG Extended Release Oral TabletSYf7f5b69a-c2a1-4586-a189-1475d41387c012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62559-280-0162559028001100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62559-280-01) 2014-07-010000-00-00NoNoCurrent