FDA.reportPublic FDA data

Lithium

Product NDC
71656-072
11-digit product format
716560072
Labeler code
71656
Product ID
71656-072_3ccc30e9-1f5d-5715-e063-6394a90a6bc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium
Dosage form
SOLUTION
Route
ORAL
Labeler
Saptalis Pharmaceuticals, LLC
Application
ANDA217183
Marketing category
ANDA
Marketing start
2024-03-28
Substance
LITHIUM CITRATE
Active strength
8 meq/5mL
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LITHIUM CITRATE8 meq/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5Z6E9K79YV
Rxcui756059

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
71656-072-05Lithium5 mL in 1 CUPSOLUTION54
71656-072-16Lithium473 mL in 1 BOTTLESOLUTION4734
71656-072-50Lithium5 in 1 CASESOLUTION54
71656-072-50Lithium10 in 1 TRAYSOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71656-072-05ML - Milliliter71656-0723d2f58b9-4f9b-47fa-aeb9-af8e09fb1ecf12024-04-05
71656-072-16ML - Milliliter71656-0721c94be83-d2b6-4c55-8ffd-3580f9bd7e9312024-04-05
71656-072-50ML - Milliliter71656-072e4fd7ce9-6fe2-49dc-8488-142e66dbf05212024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71656-072LITHIUM SOLUTION [SAPTALIS PHARMACEUTICALS, LLC]2Current NDC, 4 package rows20241116_e95036c7-542a-437a-969b-f95f6f949f84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
756059lithium ion 8 MEQ in 5 mL Oral SolutionPSNe95036c7-542a-437a-969b-f95f6f949f844
756059lithium citrate 60 MG/ML Oral SolutionSCDe95036c7-542a-437a-969b-f95f6f949f844
756059lithium citrate eqv to lithium carbonate 300 MG per 5 ML (lithium ion 8 MEQ per 5 ML) Oral SyrupSYe95036c7-542a-437a-969b-f95f6f949f844
756059lithium ion 8 MEQ per 5 ML Oral SyrupSYe95036c7-542a-437a-969b-f95f6f949f844

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71656-072-05716560072055 mL in 1 CUP5 mlHistorical
71656-072-1671656007216473 mL in 1 BOTTLE (71656-072-16) 473 ml2024-04-05NoNoCurrent
71656-072-50716560072505 TRAY in 1 CASE (71656-072-50) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (71656-072-05) 5 tray2024-03-28NoNoCurrent