Lithium

Product NDC
0121-4027
11-digit product format
001214027
Labeler code
0121
Product ID
0121-4027_bfaabf01-1b65-43db-839a-d1b66fafec18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA070755
Marketing category
ANDA
Marketing start
2026-04-14
Substance
LITHIUM CITRATE
Active strength
8 meq/5mL
Pharmacologic classes
Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lithium
Listing expiration
2027-12-31

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
0121-4027-05Lithium5 mL in 1 CUP, UNIT-DOSESOLUTION55
0121-4027-94Lithium3 in 1 CASESOLUTION35
0121-4027-94Lithium10 in 1 TRAYSOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-4027-05ML - Milliliter0121-40279dbb6e57-9541-4fc5-9c89-0fb0b522063212026-05-22
0121-4027-94ML - Milliliter0121-4027a1be0f92-087f-4967-aa57-cd0316b3be4912026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
756059lithium ion 8 MEQ in 5 mL Oral SolutionPSN677b20c4-84f0-4716-aca3-aead3bbe12835
756059lithium citrate 60 MG/ML Oral SolutionSCD677b20c4-84f0-4716-aca3-aead3bbe12835
756059lithium citrate eqv to lithium carbonate 300 MG per 5 ML (lithium ion 8 MEQ per 5 ML) Oral SyrupSY677b20c4-84f0-4716-aca3-aead3bbe12835
756059lithium ion 8 MEQ per 5 ML Oral SyrupSY677b20c4-84f0-4716-aca3-aead3bbe12835

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-4027-05001214027055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0121-4027-94001214027943 TRAY in 1 CASE (0121-4027-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4027-05) 3 tray2026-04-14NoNoHistorical