FDA.reportPublic FDA data

Lithium Carbonate

Product NDC
71335-1006
11-digit product format
713351006
Labeler code
71335
Product ID
71335-1006_8d3492c0-f641-4eee-96ba-22d36e2e97c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium Carbonate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079139
Marketing category
ANDA
Marketing start
2009-02-03
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
2027-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1006-1Lithium Carbonate60 in 1 BOTTLECAPSULE606
71335-1006-2Lithium Carbonate100 in 1 BOTTLECAPSULE1006
71335-1006-3Lithium Carbonate30 in 1 BOTTLECAPSULE306
71335-1006-4Lithium Carbonate90 in 1 BOTTLECAPSULE906
71335-1006-5Lithium Carbonate120 in 1 BOTTLECAPSULE1206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1006-4EA - Each71335-10063a4925c6-42e7-41f8-a60b-20e33bab863812019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1006LITHIUM CARBONATE CAPSULE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 5 package rows20240524_1a62d5ae-a4a3-4b10-8281-feba134bbe3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197889lithium carbonate 300 MG Oral CapsulePSN1a62d5ae-a4a3-4b10-8281-feba134bbe3a6
197889lithium carbonate 300 MG Oral CapsuleSCD1a62d5ae-a4a3-4b10-8281-feba134bbe3a6
197889LiCO3 300 MG Oral CapsuleSY1a62d5ae-a4a3-4b10-8281-feba134bbe3a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1006-17133510060160 CAPSULE in 1 BOTTLE (71335-1006-1) 60 capsule2019-05-170000-00-00NoNoCurrent
71335-1006-271335100602100 CAPSULE in 1 BOTTLE (71335-1006-2) 100 capsule2019-05-170000-00-00NoNoCurrent
71335-1006-37133510060330 CAPSULE in 1 BOTTLE (71335-1006-3) 30 capsule2019-10-180000-00-00NoNoCurrent
71335-1006-47133510060490 CAPSULE in 1 BOTTLE (71335-1006-4) 90 capsule2019-10-040000-00-00NoNoCurrent
71335-1006-571335100605120 CAPSULE in 1 BOTTLE (71335-1006-5) 120 capsule2019-05-170000-00-00NoNoCurrent