FDA.reportPublic FDA data

lithium carbonate

Product NDC
71335-0120
11-digit product format
713350120
Labeler code
71335
Product ID
71335-0120_8dcb81bf-5383-4227-8315-13469ad46a49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lithium carbonate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090702
Marketing category
ANDA
Marketing start
2009-12-15
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
lithium carbonate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LITHIUM CARBONATE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2BMD2GNA4V
Rxcui197889

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
71335-0120-1lithium carbonate60 in 1 BOTTLECAPSULE606
71335-0120-2lithium carbonate100 in 1 BOTTLECAPSULE1006
71335-0120-3lithium carbonate30 in 1 BOTTLECAPSULE306
71335-0120-4lithium carbonate90 in 1 BOTTLECAPSULE906
71335-0120-5lithium carbonate120 in 1 BOTTLECAPSULE1206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0120-1EA - Each71335-01206cc2fe5a-3791-4e8b-85f9-75f7c97306c712018-03-08
71335-0120-2EA - Each71335-0120e6aefc84-0f52-4705-8fb8-7d3ec26571a112018-03-08
71335-0120-3EA - Each71335-0120a576e120-0e2c-46ae-bd20-c1a4dd803efb12018-03-08
71335-0120-4EA - Each71335-01202e1154ab-c5eb-443d-8b0b-253e8335076d12018-03-08
71335-0120-5EA - Each71335-0120c503ba0e-8a2e-46bd-98f7-25692c52de0212018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0120LITHIUM CARBONATE (LITHIUM CARBONATE) CAPSULE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 5 package rows20230329_bfececc8-b2ab-47d1-b126-1c6592bc9c26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197889lithium carbonate 300 MG Oral CapsulePSNbfececc8-b2ab-47d1-b126-1c6592bc9c266
197889lithium carbonate 300 MG Oral CapsuleSCDbfececc8-b2ab-47d1-b126-1c6592bc9c266
197889LiCO3 300 MG Oral CapsuleSYbfececc8-b2ab-47d1-b126-1c6592bc9c266

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0120-17133501200160 CAPSULE in 1 BOTTLE (71335-0120-1) 60 capsule2021-12-160000-00-00NoNoCurrent
71335-0120-271335012002100 CAPSULE in 1 BOTTLE (71335-0120-2) 100 capsule2021-12-160000-00-00NoNoCurrent
71335-0120-37133501200330 CAPSULE in 1 BOTTLE (71335-0120-3) 30 capsule2021-12-160000-00-00NoNoCurrent
71335-0120-47133501200490 CAPSULE in 1 BOTTLE (71335-0120-4) 90 capsule2021-12-160000-00-00NoNoCurrent
71335-0120-571335012005120 CAPSULE in 1 BOTTLE (71335-0120-5) 120 capsule2021-12-160000-00-00NoNoCurrent