Potassium Citrate

Product NDC: 0245-0070
11-digit product format: 002450070
Labeler code: 0245
Product ID: 0245-0070_39e81850-ac5b-656e-e063-6294a90a1d94
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: potassium citrate
Dosage form: TABLET
Route: ORAL
Labeler: Upsher-Smith Laboratories, LLC
Application: NDA019071
Marketing category: NDA
Marketing start: 2006-09-01
Marketing end: 2027-07-31
Substance: POTASSIUM CITRATE
Active strength: 5 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
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 · 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 · 126 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
2026-08-18 06:07:40	2026-07	N019071-001	UROCIT-K	5MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1985-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019071-002	UROCIT-K	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019071-003	UROCIT-K	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-12-30	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	N019071-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019071-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019071-003	AB	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Potassium Citrate

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM CITRATE	5 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 · 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
2215dc1d-0b5a-469e-9b51-4d7480a51078	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
0245-0070-11	Potassium Citrate	100 in 1 BOTTLE	TABLET	100		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0245-0070-11	EA - Each	0245-0070	9c645a9a-ecac-4b99-891b-42938610da3b	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
potassium citrate	ACTIVE INGREDIENT	EE90ONI6FF	POTASSIUM CITRATE TABLET [UPSHER-SMITH LABORATORIES, INC.]	3
anhydrous citric acid	ACTIVE MOIETY	XF417D3PSL	POTASSIUM CITRATE TABLET [UPSHER-SMITH LABORATORIES, INC.]	3
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	POTASSIUM CITRATE TABLET [UPSHER-SMITH LABORATORIES, INC.]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	POTASSIUM CITRATE TABLET [UPSHER-SMITH LABORATORIES, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0245-0070	POTASSIUM CITRATE TABLET [UPSHER-SMITH LABORATORIES, LLC]	6	Current NDC, Legacy NDC, 1 package rows	20220812_2215dc1d-0b5a-469e-9b51-4d7480a51078.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
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 ndc (product): 0245-0070
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

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	2215dc1d-0b5a-469e-9b51-4d7480a51078	7
199376	potassium citrate 5 MEQ Extended Release Oral Tablet	PSN	2215dc1d-0b5a-469e-9b51-4d7480a51078	7
199381	potassium citrate 10 MEQ Extended Release Oral Tablet	SCD	2215dc1d-0b5a-469e-9b51-4d7480a51078	7
199376	potassium citrate 5 MEQ Extended Release Oral Tablet	SCD	2215dc1d-0b5a-469e-9b51-4d7480a51078	7
199381	K+ citrate 10 MEQ Extended Release Oral Tablet	SY	2215dc1d-0b5a-469e-9b51-4d7480a51078	7
199376	K+ citrate 5 MEQ Extended Release Oral Tablet	SY	2215dc1d-0b5a-469e-9b51-4d7480a51078	7
199381	Pot citrate 10 MEQ Extended Release Oral Tablet	SY	2215dc1d-0b5a-469e-9b51-4d7480a51078	7
199376	Pot citrate 5 MEQ Extended Release Oral Tablet	SY	2215dc1d-0b5a-469e-9b51-4d7480a51078	7
199381	potassium citrate 1080 MG Extended Release Oral Tablet	SY	2215dc1d-0b5a-469e-9b51-4d7480a51078	7
199376	potassium citrate 540 MG Extended Release Oral Tablet	SY	2215dc1d-0b5a-469e-9b51-4d7480a51078	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0245-0070-11	00245007011	100 TABLET in 1 BOTTLE (0245-0070-11)	100 tablet	2006-09-01	2027-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Potassium Citrate	Upsher-Smith Laboratories, LLC \| Mission Pharmacal Company	2025-07-14	HUMAN PRESCRIPTION DRUG LABEL	7