Lithium

Product NDC: 68094-077
11-digit product format: 680940077
Labeler code: 68094
Product ID: 68094-077_78d523ef-d924-4154-9b2b-3d5a79a75052
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lithium Citrate
Dosage form: SOLUTION
Route: ORAL
Labeler: Precision Dose, Inc.
Application: ANDA218036
Marketing category: ANDA
Marketing start: 2025-10-24
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
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
2026-02-19 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
2026-02-19 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…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a12d50fb-2c2f-4105-ad17-adbf90d439d4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b3053bb1-353b-4a0b-bca5-28fe7228957c	Product name	2	20250124
8ce6e144-236f-b7be-f690-f06e0c8c6bd3	Product name	2	20170725
f09af6ee-c6dd-d0ce-77ad-93508bcdaced	Product name	4	20161205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68094-077-59	Lithium	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	1
68094-077-62	Lithium	3 in 1 CASE	SOLUTION	3	1
68094-077-62	Lithium	10 in 1 TRAY	SOLUTION	10	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68094-077-59	ML - Milliliter	68094-077	ec897abd-38f2-4d38-a574-a328f6bdfe42	1	2026-01-08
68094-077-62	ML - Milliliter	68094-077	b7a30654-fbec-4b86-9cfc-00c6d84d7fec	1	2026-01-08

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	Advagen Pharma Ltd	ff9baf45-830f-4a8a-8986-5caeaa1b38cf	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218036 application number: ANDA218036
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 ndc (product): 68094-077
Lithium	LITHIUM	REMEDYREPACK INC.	be1346df-4a39-45e8-874b-e2a496847fd5	2025-09-30	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
756059	lithium ion 8 MEQ in 5 mL Oral Solution	PSN	a12d50fb-2c2f-4105-ad17-adbf90d439d4	1
756059	lithium citrate 60 MG/ML Oral Solution	SCD	a12d50fb-2c2f-4105-ad17-adbf90d439d4	1
756059	lithium citrate eqv to lithium carbonate 300 MG per 5 ML (lithium ion 8 MEQ per 5 ML) Oral Syrup	SY	a12d50fb-2c2f-4105-ad17-adbf90d439d4	1
756059	lithium ion 8 MEQ per 5 ML Oral Syrup	SY	a12d50fb-2c2f-4105-ad17-adbf90d439d4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68094-077-59	68094007759	5 mL in 1 CUP, UNIT-DOSE	5 ml				Historical
68094-077-62	68094007762	3 TRAY in 1 CASE (68094-077-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-077-59)	3 tray	2025-10-24	No	No	Current