FDA.reportPublic FDA data

Lithium

Product NDC
72888-172
11-digit product format
728880172
Labeler code
72888
Product ID
72888-172_47c8d276-05d5-8641-e063-6294a90a8bbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium
Dosage form
SOLUTION
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA218036
Marketing category
ANDA
Marketing start
2022-11-09
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218036-001LITHIUM CITRATELITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAARS2023-08-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A218036-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A218036-001LITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAARS2023-08-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218036-001LITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAARS2023-08-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A218036-001LITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAARS2023-08-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218036-001LITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAARS2023-08-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218036-001LITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAARS2023-08-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218036-001LITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAARS2023-08-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218036-001LITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAARS2023-08-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218036-001LITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAARS2023-08-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218036-001LITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAARS2023-08-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218036-001LITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAARS2023-08-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218036-001LITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAARS2023-08-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218036-001LITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAARS2023-08-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218036-001LITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAARS2023-08-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A218036-001LITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAARS2023-08-148072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A218036-001LITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAARS2023-08-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A218036-001LITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAA2023-08-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A218036-001LITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAA2023-08-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A218036-001LITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAA2023-08-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A218036-001LITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAA2023-08-149b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218036-001LITHIUM CITRATEEQ 300MG CARBONATE/5MLSYRUP / ORALAARS2023-08-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218036-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218036-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218036-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218036-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218036-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218036-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218036-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218036-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218036-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218036-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218036-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218036-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218036-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A218036-001AA18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A218036-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A218036-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A218036-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A218036-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A218036-001AA19b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218036-001AA1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218036-001CGT2024-03-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218036-001CGT2024-03-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218036-001CGT2024-03-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218036-001CGT2024-03-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218036-001CGT2024-03-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218036-001CGT2024-03-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218036-001CGT2024-03-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218036-001CGT2024-03-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A218036-001CGT2024-03-188072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A218036-001CGT2024-03-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A218036-001CGT2024-03-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A218036-001CGT2024-03-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A218036-001CGT2024-03-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A218036-001CGT2024-03-189b2671bbb829…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5Z6E9K79YVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
756059Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff9baf45-830f-4a8a-8986-5caeaa1b38cfAvailable on FDA.report

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
72888-172-46Lithium500 mL in 1 BOTTLESOLUTION5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-172-46ML - Milliliter72888-172b1c37f73-25e7-4313-9864-4a27e7331e8e12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-172LITHIUM SOLUTION [ADVAGEN PHARMA LTD]4Current NDC, 1 package rows20230826_ff9baf45-830f-4a8a-8986-5caeaa1b38cf.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LithiumLITHIUMAdvagen Pharma Ltdff9baf45-830f-4a8a-8986-5caeaa1b38cf2026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218036
application number: ANDA218036
ndc (product): 72888-172
LithiumLITHIUM CITRATEPrecision Dose, Inc.a12d50fb-2c2f-4105-ad17-adbf90d439d42025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218036
application number: ANDA218036
LithiumLITHIUMREMEDYREPACK INC.be1346df-4a39-45e8-874b-e2a496847fd52025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218036
application number: ANDA218036

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
756059lithium ion 8 MEQ in 5 mL Oral SolutionPSNff9baf45-830f-4a8a-8986-5caeaa1b38cf5
756059lithium citrate 60 MG/ML Oral SolutionSCDff9baf45-830f-4a8a-8986-5caeaa1b38cf5
756059lithium citrate eqv to lithium carbonate 300 MG per 5 ML (lithium ion 8 MEQ per 5 ML) Oral SyrupSYff9baf45-830f-4a8a-8986-5caeaa1b38cf5
756059lithium ion 8 MEQ per 5 ML Oral SyrupSYff9baf45-830f-4a8a-8986-5caeaa1b38cf5
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
756059lithium ion 8 MEQ in 5 mL Oral SolutionPSNa12d50fb-2c2f-4105-ad17-adbf90d439d41
756059lithium citrate 60 MG/ML Oral SolutionSCDa12d50fb-2c2f-4105-ad17-adbf90d439d41
756059lithium citrate eqv to lithium carbonate 300 MG per 5 ML (lithium ion 8 MEQ per 5 ML) Oral SyrupSYa12d50fb-2c2f-4105-ad17-adbf90d439d41
756059lithium ion 8 MEQ per 5 ML Oral SyrupSYa12d50fb-2c2f-4105-ad17-adbf90d439d41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-172-4672888017246500 mL in 1 BOTTLE (72888-172-46) 500 ml2022-11-09NoNoCurrent