Lithium

Product NDC: 70518-4227
11-digit product format: 705184227
Labeler code: 70518
Product ID: 70518-4227_400519aa-488a-40e4-e063-6394a90a8d39
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lithium
Dosage form: SOLUTION
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA218036
Marketing category: ANDA
Marketing start: 2024-11-04
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
be1346df-4a39-45e8-874b-e2a496847fd5	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
70518-4227-0	Lithium	10 in 1 BOX	SOLUTION	10	3
70518-4227-1	Lithium	5 mL in 1 CUP	SOLUTION	5	3
70518-4227-2	Lithium	10 in 1 BOX	SOLUTION	10	3
70518-4227-3	Lithium	10 mL in 1 CUP, UNIT-DOSE	SOLUTION	10	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4227	LITHIUM SOLUTION [REMEDYREPACK INC.]	2	Current NDC, 4 package rows	20241213_be1346df-4a39-45e8-874b-e2a496847fd5.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
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
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 ndc (product): 70518-4227

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

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	be1346df-4a39-45e8-874b-e2a496847fd5	3
756059	lithium citrate 60 MG/ML Oral Solution	SCD	be1346df-4a39-45e8-874b-e2a496847fd5	3
756059	lithium citrate eqv to lithium carbonate 300 MG per 5 ML (lithium ion 8 MEQ per 5 ML) Oral Syrup	SY	be1346df-4a39-45e8-874b-e2a496847fd5	3
756059	lithium ion 8 MEQ per 5 ML Oral Syrup	SY	be1346df-4a39-45e8-874b-e2a496847fd5	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4227-0	70518422700	10 CUP in 1 BOX (70518-4227-0) / 5 mL in 1 CUP (70518-4227-1)	10 cup	2024-11-04	No	No	Current
70518-4227-1	70518422701	5 mL in 1 CUP	5 ml				Historical
70518-4227-2	70518422702	10 CUP, UNIT-DOSE in 1 BOX (70518-4227-2) / 10 mL in 1 CUP, UNIT-DOSE (70518-4227-3)		2024-11-05	No	No	Current
70518-4227-3	70518422703	10 mL in 1 CUP, UNIT-DOSE	10 ml				Historical