Lithium

Product NDC: 17856-1172
11-digit product format: 178561172
Labeler code: 17856
Product ID: 17856-1172_59d0e8f4-b6ae-0e36-e063-6394a90ac136
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lithium
Dosage form: SOLUTION
Route: ORAL
Labeler: Atlantic Biologicals Corp.
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 43.

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
A218036-001	LITHIUM CITRATE	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	2023-08-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218036-001	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
2026-09-14 22:38:34	2026-08	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	2023-08-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	2023-08-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	2023-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	2023-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	2023-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	2023-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	2023-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	2023-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	2023-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	2023-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	2023-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	2023-08-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	2023-08-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	2023-08-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	2023-08-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	2023-08-14	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	2023-08-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA		2023-08-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA		2023-08-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA		2023-08-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA		2023-08-14	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218036-001	LITHIUM CITRATE	EQ 300MG CARBONATE/5ML	SYRUP / ORAL	AA	RS	2023-08-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218036-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218036-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218036-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218036-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218036-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218036-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218036-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218036-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218036-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218036-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218036-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218036-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218036-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218036-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218036-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218036-001	AA	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A218036-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A218036-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A218036-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A218036-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A218036-001	AA	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218036-001	AA	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218036-001	CGT	2024-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218036-001	CGT	2024-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218036-001	CGT	2024-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218036-001	CGT	2024-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218036-001	CGT	2024-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218036-001	CGT	2024-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218036-001	CGT	2024-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218036-001	CGT	2024-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218036-001	CGT	2024-03-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A218036-001	CGT	2024-03-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A218036-001	CGT	2024-03-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A218036-001	CGT	2024-03-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A218036-001	CGT	2024-03-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A218036-001	CGT	2024-03-18	`9b2671bbb829…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
59d0e8e3-bc0b-0cc1-e063-6394a90a0a6d	Available on FDA.report

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lithium	LITHIUM	REMEDYREPACK INC.	be1346df-4a39-45e8-874b-e2a496847fd5	2026-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218036 application number: ANDA218036
Lithium	LITHIUM	Atlantic Biologicals Corp.	59d0e8e3-bc0b-0cc1-e063-6394a90a0a6d	2026-08-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218036 application number: ANDA218036 ndc (product): 17856-1172
Lithium	LITHIUM CITRATE	Precision Dose, Inc.	a12d50fb-2c2f-4105-ad17-adbf90d439d4	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218036 application number: ANDA218036

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5Z6E9K79YV	LITHIUM CITRATE	6080-58-6	LITHIUM CITRATE
9FN79X2M3F	LITHIUM	7439-93-2	Lithium

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
17856-1172-1	17856117201	30 SYRINGE in 1 CASE (17856-1172-1) / 15 mL in 1 SYRINGE	30 syringe	2026-08-24	No	No	Current