POTASSIUM CITRATE

Product NDC: 16571-865
11-digit product format: 165710865
Labeler code: 16571
Product ID: 16571-865_2e4e8acc-d3ad-4246-bd65-d95691896fc8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: potassium citrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA077440
Marketing category: ANDA
Marketing start: 2024-12-15
Substance: POTASSIUM CITRATE
Active strength: 1080 mg/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
A077440-001	POTASSIUM CITRATE	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB		2006-06-08
A077440-002	POTASSIUM CITRATE	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB		2006-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077440-001	AB
A077440-002	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 3 · 84 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	A077440-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077440-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077440-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077440-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077440-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077440-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077440-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077440-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077440-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077440-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077440-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077440-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077440-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077440-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077440-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077440-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077440-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077440-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077440-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077440-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077440-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077440-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077440-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077440-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077440-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077440-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077440-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077440-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077440-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077440-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077440-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077440-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077440-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077440-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077440-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077440-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077440-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077440-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077440-001	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077440-002	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	2006-06-09	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A077440-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077440-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077440-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077440-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077440-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077440-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077440-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077440-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077440-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077440-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077440-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077440-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077440-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077440-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077440-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077440-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077440-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077440-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077440-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077440-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077440-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077440-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077440-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077440-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077440-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077440-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077440-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077440-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077440-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077440-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077440-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077440-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077440-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077440-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077440-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077440-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077440-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077440-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077440-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077440-002	AB	1	`bb7c543d1eb4…`

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	1080 mg/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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199376	Internal RxNorm lookup
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
164d9d05-fbb1-4d99-8ba3-ff9c172aa8ca	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16571-865-01	POTASSIUM CITRATE	100 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-865-01	EA - Each	16571-865	e9dd24c1-9a36-4e52-aae7-5f31558b68f6	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-865	POTASSIUM CITRATE TABLET, EXTENDED RELEASE [RISING PHARMA HOLDINGS, INC.]	4	Current NDC, 1 package rows	20250215_164d9d05-fbb1-4d99-8ba3-ff9c172aa8ca.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
POTASSIUM CITRATE	POTASSIUM CITRATE	Rising Pharma Holdings, Inc.	164d9d05-fbb1-4d99-8ba3-ff9c172aa8ca	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077440 application number: ANDA077440 ndc (product): 16571-865

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	164d9d05-fbb1-4d99-8ba3-ff9c172aa8ca	5
199376	potassium citrate 5 MEQ Extended Release Oral Tablet	PSN	164d9d05-fbb1-4d99-8ba3-ff9c172aa8ca	5
199381	potassium citrate 10 MEQ Extended Release Oral Tablet	SCD	164d9d05-fbb1-4d99-8ba3-ff9c172aa8ca	5
199376	potassium citrate 5 MEQ Extended Release Oral Tablet	SCD	164d9d05-fbb1-4d99-8ba3-ff9c172aa8ca	5
199381	K+ citrate 10 MEQ Extended Release Oral Tablet	SY	164d9d05-fbb1-4d99-8ba3-ff9c172aa8ca	5
199376	K+ citrate 5 MEQ Extended Release Oral Tablet	SY	164d9d05-fbb1-4d99-8ba3-ff9c172aa8ca	5
199381	Pot citrate 10 MEQ Extended Release Oral Tablet	SY	164d9d05-fbb1-4d99-8ba3-ff9c172aa8ca	5
199376	Pot citrate 5 MEQ Extended Release Oral Tablet	SY	164d9d05-fbb1-4d99-8ba3-ff9c172aa8ca	5
199381	potassium citrate 1080 MG Extended Release Oral Tablet	SY	164d9d05-fbb1-4d99-8ba3-ff9c172aa8ca	5
199376	potassium citrate 540 MG Extended Release Oral Tablet	SY	164d9d05-fbb1-4d99-8ba3-ff9c172aa8ca	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
16571-865-01	16571086501	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16571-865-01)	2024-12-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
POTASSIUM CITRATE	Rising Pharma Holdings, Inc. \| Cohance Lifesciences Limited	2026-07-14	Human Prescription Drug Label	6