Home NDC 71656-072 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 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 A217183-001 LITHIUM CITRATE LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 2024-03-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217183-001 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.
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 A217183-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 2024-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217183-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 2024-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217183-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 2024-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217183-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 2024-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217183-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 2024-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217183-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 2024-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217183-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 2024-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217183-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 2024-03-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217183-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 2024-03-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217183-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 2024-03-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217183-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 2024-03-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217183-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 2024-03-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217183-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 2024-03-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217183-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 2024-03-18 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217183-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 2024-02-29 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217183-001 LITHIUM CITRATE EQ 300MG CARBONATE/5ML SYRUP / ORAL AA 2024-03-18 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Lithium
Listing expiration 2026-12-31 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 71656-072-05 Lithium 5 mL in 1 CUP SOLUTION 5 4 71656-072-16 Lithium 473 mL in 1 BOTTLE SOLUTION 473 4 71656-072-50 Lithium 5 in 1 CASE SOLUTION 5 4 71656-072-50 Lithium 10 in 1 TRAY SOLUTION 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71656-072 LITHIUM SOLUTION [SAPTALIS PHARMACEUTICALS, LLC] 2 Current NDC, 4 package rows 20241116_e95036c7-542a-437a-969b-f95f6f949f84.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lithium LITHIUM Saptalis Pharmaceuticals, LLC e95036c7-542a-437a-969b-f95f6f949f84 2025-08-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 217183 application number: ANDA217183 ndc (product): 71656-072
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71656-072-05 71656007205 5 mL in 1 CUP 5 ml Historical 71656-072-16 71656007216 473 mL in 1 BOTTLE (71656-072-16) 473 ml 2024-04-05 No No Current 71656-072-50 71656007250 5 TRAY in 1 CASE (71656-072-50) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (71656-072-05) 5 tray 2024-03-28 No No Current