UROCIT-K

Product NDC: 70518-0086
11-digit product format: 705180086
Labeler code: 70518
Product ID: 70518-0086_8038189d-9276-2656-e053-2991aa0a7fc5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: potassium citrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA019071
Marketing category: NDA
Marketing start: 2016-12-27
Marketing end: 0000-00-00
Substance: POTASSIUM CITRATE
Active strength: 10 meq/1
Pharmacologic classes: Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70518-0086		D	Discontinued by firm		2026-08-07
excluded package	package	70518-0086	70518-0086-0	D	Discontinued by firm		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-0086-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-0086-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-0086-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-0086-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-0086-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-0086-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-0086-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-0086-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-0086-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-0086-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-0086-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-0086-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019071-001	UROCIT-K	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1985-08-30
N019071-002	UROCIT-K	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-08-31
N019071-003	UROCIT-K	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-12-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N019071-001	AB
N019071-002	AB
N019071-003	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 4 · 123 observed 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	N019071-001	UROCIT-K	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1985-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019071-002	UROCIT-K	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019071-003	UROCIT-K	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019071-001	UROCIT-K	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1985-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019071-002	UROCIT-K	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019071-003	UROCIT-K	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019071-001	UROCIT-K	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1985-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019071-002	UROCIT-K	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-08-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019071-003	UROCIT-K	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019071-001	UROCIT-K	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1985-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019071-002	UROCIT-K	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-08-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019071-003	UROCIT-K	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019071-001	UROCIT-K	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1985-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019071-002	UROCIT-K	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-08-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019071-003	UROCIT-K	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019071-001	UROCIT-K	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1985-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019071-002	UROCIT-K	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-08-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019071-003	UROCIT-K	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019071-001	UROCIT-K	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1985-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019071-002	UROCIT-K	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-08-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019071-003	UROCIT-K	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019071-001	UROCIT-K	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1985-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019071-002	UROCIT-K	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-08-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019071-003	UROCIT-K	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019071-001	UROCIT-K	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1985-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019071-002	UROCIT-K	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-08-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019071-003	UROCIT-K	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019071-001	UROCIT-K	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1985-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019071-002	UROCIT-K	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-08-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019071-003	UROCIT-K	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019071-001	UROCIT-K	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1985-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019071-002	UROCIT-K	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-08-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019071-003	UROCIT-K	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019071-001	UROCIT-K	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1985-08-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019071-002	UROCIT-K	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019071-003	UROCIT-K	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019071-001	UROCIT-K	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1985-08-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019071-002	UROCIT-K	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-08-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019071-003	UROCIT-K	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019071-001	UROCIT-K	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1985-08-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019071-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019071-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019071-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019071-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019071-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019071-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019071-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019071-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019071-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019071-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019071-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019071-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019071-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019071-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019071-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019071-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019071-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019071-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019071-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019071-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019071-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019071-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019071-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019071-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019071-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019071-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019071-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019071-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019071-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019071-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019071-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019071-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019071-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019071-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019071-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019071-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019071-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019071-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019071-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019071-001	AB	1	`8072bd15b7f6…`

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
Potassium Citrate	POTASSIUM CITRATE	Biocomp Pharma, Inc.	b32fe71a-4a58-04a1-64d3-bc3cc4a895bf	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019071 application number: NDA019071
Potassium Citrate	POTASSIUM CITRATE	Upsher-Smith Laboratories, LLC	2215dc1d-0b5a-469e-9b51-4d7480a51078	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019071 application number: NDA019071
UROCIT-K	POTASSIUM CITRATE	Mission Pharmacal Company	72cdea1b-2240-41db-987d-86d5c6aaa978	2021-12-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019071 application number: NDA019071