Potassium Citrate

Product NDC: 70518-3160
11-digit product format: 705183160
Labeler code: 70518
Product ID: 70518-3160_4ec9e26c-9caf-0355-e063-6294a90ac9e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Potassium Citrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA212779
Marketing category: ANDA
Marketing start: 2021-07-15
Substance: POTASSIUM CITRATE
Active strength: 10 meq/1
Pharmacologic classes: Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212779-001	POTASSIUM CITRATE	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB		2020-01-14
A212779-002	POTASSIUM CITRATE	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB		2020-01-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A212779-001	AB
A212779-002	AB

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 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212779-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212779-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212779-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212779-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212779-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212779-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212779-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212779-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212779-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212779-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212779-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212779-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212779-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212779-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212779-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212779-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212779-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212779-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212779-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212779-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212779-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212779-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212779-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212779-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212779-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212779-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212779-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212779-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212779-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212779-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212779-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212779-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212779-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212779-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212779-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212779-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212779-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212779-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212779-001	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212779-002	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2020-01-14	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212779-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212779-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212779-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212779-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212779-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212779-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212779-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212779-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212779-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212779-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212779-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212779-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212779-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212779-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212779-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212779-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212779-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212779-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212779-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212779-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212779-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212779-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212779-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212779-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212779-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212779-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212779-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212779-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212779-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212779-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212779-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212779-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212779-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212779-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212779-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212779-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212779-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212779-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212779-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212779-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Potassium Citrate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM CITRATE	10 meq/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EE90ONI6FF	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199381	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
a9cc636d-3e26-450c-9df8-665d530d626f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-3160-0	Potassium Citrate	100 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	100		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3160	POTASSIUM CITRATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]	4	Current NDC, Legacy NDC, 1 package rows	20240315_a9cc636d-3e26-450c-9df8-665d530d626f.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Citrate	POTASSIUM CITRATE	Bryant Ranch Prepack	ff67f638-5b53-406a-962a-87773a91fc48	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212779 application number: ANDA212779
Potassium Citrate	POTASSIUM CITRATE	REMEDYREPACK INC.	a9cc636d-3e26-450c-9df8-665d530d626f	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212779 application number: ANDA212779 ndc (product): 70518-3160
Potassium Citrate	POTASSIUM CITRATE	Bryant Ranch Prepack	6271d84e-d991-4bb8-ac9f-6d5cc879b631	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212779 application number: ANDA212779
Potassium Citrate	POTASSIUM CITRATE	Bryant Ranch Prepack	595343aa-b760-4158-9c49-dd5368f45e2c	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212779 application number: ANDA212779
Potassium Citrate	POTASSIUM CITRATE	ANI Pharmaceuticals, Inc.	2fb31727-68b1-4183-947d-00e08bf99987	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212779 application number: ANDA212779
Potassium Citrate	POTASSIUM CITRATE	Bryant Ranch Prepack	ebf1f1f1-4458-4d34-8432-21698a550e07	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212779 application number: ANDA212779
Potassium Citrate	POTASSIUM CITRATE	Bryant Ranch Prepack	f2ab3c2e-2a6e-4698-afad-260bdf0d259e	2024-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212779 application number: ANDA212779

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EE90ONI6FF	POTASSIUM CITRATE	6100-05-6	POTASSIUM CITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199381	potassium citrate 10 MEQ Extended Release Oral Tablet	PSN	a9cc636d-3e26-450c-9df8-665d530d626f	6
199381	potassium citrate 10 MEQ Extended Release Oral Tablet	SCD	a9cc636d-3e26-450c-9df8-665d530d626f	6
199381	K+ citrate 10 MEQ Extended Release Oral Tablet	SY	a9cc636d-3e26-450c-9df8-665d530d626f	6
199381	Pot citrate 10 MEQ Extended Release Oral Tablet	SY	a9cc636d-3e26-450c-9df8-665d530d626f	6
199381	potassium citrate 1080 MG Extended Release Oral Tablet	SY	a9cc636d-3e26-450c-9df8-665d530d626f	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3160-0	70518316000	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3160-0)	2021-07-15	0000-00-00	No	No	Current