Home NDC 0121-4027 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070755-001 LITHIUM CITRATE LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 1986-05-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070755-001 AA
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.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL 1986-05-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL 1986-05-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL 1986-05-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL 1986-05-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL 1986-05-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL 1986-05-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL 1986-05-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL 1986-05-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL 1986-05-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL 1986-05-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL 1986-05-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL 1986-05-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL 1986-05-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL 1986-05-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL RS 1986-05-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 1986-05-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 1986-05-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 1986-05-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 1986-05-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 1986-05-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 1986-05-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 1986-05-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 1986-05-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 1986-05-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 1986-05-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 1986-05-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 1986-05-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL 1986-05-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA RS 1986-05-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA RS 1986-05-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA RS 1986-05-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA RS 1986-05-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL RS 1986-05-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL RS 1986-05-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL RS 1986-05-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL RS 1986-05-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL RS 1986-05-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL RS 1986-05-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL RS 1986-05-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A070755-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL RS 1986-05-21 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Lithium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LITHIUM CITRATE 8 meq/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5Z6E9K79YV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 756059 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0121-4027-05 Lithium 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 5 0121-4027-94 Lithium 3 in 1 CASE SOLUTION 3 5 0121-4027-94 Lithium 10 in 1 TRAY SOLUTION 10 5
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lithium LITHIUM PAI Holdings, LLC dba PAI Pharma 677b20c4-84f0-4716-aca3-aead3bbe1283 2025-01-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070755 application number: ANDA070755 ndc (product): 0121-4027
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0121-4027-05 00121402705 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 0121-4027-94 00121402794 3 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 tray 2026-04-14 No No Current