FDA.reportPublic FDA data

Lithium

Product NDC
70518-4227
11-digit product format
705184227
Labeler code
70518
Product ID
70518-4227_400519aa-488a-40e4-e063-6394a90a8d39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium
Dosage form
SOLUTION
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA218036
Marketing category
ANDA
Marketing start
2024-11-04
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
70518-4227-0Lithium10 in 1 BOXSOLUTION103
70518-4227-1Lithium5 mL in 1 CUPSOLUTION53
70518-4227-2Lithium10 in 1 BOXSOLUTION103
70518-4227-3Lithium10 mL in 1 CUP, UNIT-DOSESOLUTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4227LITHIUM SOLUTION [REMEDYREPACK INC.]2Current NDC, 4 package rows20241213_be1346df-4a39-45e8-874b-e2a496847fd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
756059lithium ion 8 MEQ in 5 mL Oral SolutionPSNbe1346df-4a39-45e8-874b-e2a496847fd53
756059lithium citrate 60 MG/ML Oral SolutionSCDbe1346df-4a39-45e8-874b-e2a496847fd53
756059lithium citrate eqv to lithium carbonate 300 MG per 5 ML (lithium ion 8 MEQ per 5 ML) Oral SyrupSYbe1346df-4a39-45e8-874b-e2a496847fd53
756059lithium ion 8 MEQ per 5 ML Oral SyrupSYbe1346df-4a39-45e8-874b-e2a496847fd53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4227-07051842270010 CUP in 1 BOX (70518-4227-0) / 5 mL in 1 CUP (70518-4227-1) 10 cup2024-11-04NoNoHistorical
70518-4227-1705184227015 mL in 1 CUP5 mlHistorical
70518-4227-27051842270210 CUP, UNIT-DOSE in 1 BOX (70518-4227-2) / 10 mL in 1 CUP, UNIT-DOSE (70518-4227-3) 2024-11-05NoNoHistorical
70518-4227-37051842270310 mL in 1 CUP, UNIT-DOSE10 mlHistorical