UROCIT-K

Product NDC: 0178-0615
11-digit product format: 001780615
Labeler code: 0178
Product ID: 0178-0615_44ffdb97-c338-85b4-e063-6294a90a418a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: potassium citrate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Mission Pharmacal Company
Application: NDA019071
Marketing category: NDA
Marketing start: 2010-01-27
Substance: POTASSIUM CITRATE
Active strength: 15 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: 2026-12-31
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 · 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: UROCIT-K
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM CITRATE	15 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199376	Internal RxNorm lookup
199381	Internal RxNorm lookup
603281	Internal RxNorm lookup
603282	Internal RxNorm lookup
898490	Internal RxNorm lookup
898517	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
72cdea1b-2240-41db-987d-86d5c6aaa978	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
d9771140-739b-484b-ae64-b79528ff1211	Product name	3	20250801
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0178-0615-01	UROCIT-K	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0178-0615-01	EA - Each	0178-0615	806f192c-4120-484f-8da2-44536fbe45f4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
potassium citrate	ACTIVE INGREDIENT	EE90ONI6FF	UROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [MISSION PHARMACAL COMPANY]	2
potassium cation	ACTIVE MOIETY	295O53K152	UROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [MISSION PHARMACAL COMPANY]	2
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	UROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [MISSION PHARMACAL COMPANY]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	UROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [MISSION PHARMACAL COMPANY]	2
POTASSIUM CITRATE	ACTIVE INGREDIENT	EE90ONI6FF	UROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
POTASSIUM CATION	ACTIVE MOIETY	295O53K152	UROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	UROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	UROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0178-0615	UROCIT-K (POTASSIUM CITRATE) TABLET, EXTENDED RELEASE [MISSION PHARMACAL COMPANY]	26	Current NDC, Legacy NDC, 1 package rows	20240529_72cdea1b-2240-41db-987d-86d5c6aaa978.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
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 ndc (product): 0178-0615

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	72cdea1b-2240-41db-987d-86d5c6aaa978	28
898490	potassium citrate 15 MEQ Extended Release Oral Tablet	PSN	72cdea1b-2240-41db-987d-86d5c6aaa978	28
199376	potassium citrate 5 MEQ Extended Release Oral Tablet	PSN	72cdea1b-2240-41db-987d-86d5c6aaa978	28
603281	UROCIT-K 10 MEQ Extended Release Oral Tablet	PSN	72cdea1b-2240-41db-987d-86d5c6aaa978	28
898517	UROCIT-K 15 MEQ Extended Release Oral Tablet	PSN	72cdea1b-2240-41db-987d-86d5c6aaa978	28
603282	UROCIT-K 5 MEQ Extended Release Oral Tablet	PSN	72cdea1b-2240-41db-987d-86d5c6aaa978	28
603281	potassium citrate 10 MEQ Extended Release Oral Tablet [Urocit-K]	SBD	72cdea1b-2240-41db-987d-86d5c6aaa978	28
898517	potassium citrate 15 MEQ Extended Release Oral Tablet [Urocit-K]	SBD	72cdea1b-2240-41db-987d-86d5c6aaa978	28
603282	potassium citrate 5 MEQ Extended Release Oral Tablet [Urocit-K]	SBD	72cdea1b-2240-41db-987d-86d5c6aaa978	28
199381	potassium citrate 10 MEQ Extended Release Oral Tablet	SCD	72cdea1b-2240-41db-987d-86d5c6aaa978	28
898490	potassium citrate 15 MEQ Extended Release Oral Tablet	SCD	72cdea1b-2240-41db-987d-86d5c6aaa978	28
199376	potassium citrate 5 MEQ Extended Release Oral Tablet	SCD	72cdea1b-2240-41db-987d-86d5c6aaa978	28
199381	K+ citrate 10 MEQ Extended Release Oral Tablet	SY	72cdea1b-2240-41db-987d-86d5c6aaa978	28
603281	K+ citrate 10 MEQ Extended Release Oral Tablet [Urocit-K]	SY	72cdea1b-2240-41db-987d-86d5c6aaa978	28
898490	K+ citrate 15 MEQ Extended Release Oral Tablet	SY	72cdea1b-2240-41db-987d-86d5c6aaa978	28
898517	K+ citrate 15 MEQ Extended Release Oral Tablet [Urocit-K]	SY	72cdea1b-2240-41db-987d-86d5c6aaa978	28
199376	K+ citrate 5 MEQ Extended Release Oral Tablet	SY	72cdea1b-2240-41db-987d-86d5c6aaa978	28
603282	K+ citrate 5 MEQ Extended Release Oral Tablet [Urocit-K]	SY	72cdea1b-2240-41db-987d-86d5c6aaa978	28
199381	Pot citrate 10 MEQ Extended Release Oral Tablet	SY	72cdea1b-2240-41db-987d-86d5c6aaa978	28
603281	Pot citrate 10 MEQ Extended Release Oral Tablet [Urocit-K]	SY	72cdea1b-2240-41db-987d-86d5c6aaa978	28
898490	Pot citrate 15 MEQ Extended Release Oral Tablet	SY	72cdea1b-2240-41db-987d-86d5c6aaa978	28
898517	Pot citrate 15 MEQ Extended Release Oral Tablet [Urocit-K]	SY	72cdea1b-2240-41db-987d-86d5c6aaa978	28
199376	Pot citrate 5 MEQ Extended Release Oral Tablet	SY	72cdea1b-2240-41db-987d-86d5c6aaa978	28
603282	Pot citrate 5 MEQ Extended Release Oral Tablet [Urocit-K]	SY	72cdea1b-2240-41db-987d-86d5c6aaa978	28
199381	potassium citrate 1080 MG Extended Release Oral Tablet	SY	72cdea1b-2240-41db-987d-86d5c6aaa978	28
898490	potassium citrate 1620 MG Extended Release Oral Tablet	SY	72cdea1b-2240-41db-987d-86d5c6aaa978	28
199376	potassium citrate 540 MG Extended Release Oral Tablet	SY	72cdea1b-2240-41db-987d-86d5c6aaa978	28
603281	Urocit-K 10 MEQ Extended Release Oral Tablet	SY	72cdea1b-2240-41db-987d-86d5c6aaa978	28
898517	Urocit-K 15 MEQ Extended Release Oral Tablet	SY	72cdea1b-2240-41db-987d-86d5c6aaa978	28
898517	Urocit-K 1620 MG Extended Release Oral Tablet	SY	72cdea1b-2240-41db-987d-86d5c6aaa978	28
603282	Urocit-K 5 MEQ Extended Release Oral Tablet	SY	72cdea1b-2240-41db-987d-86d5c6aaa978	28
199381	potassium citrate 10 MEQ Extended Release Oral Tablet	PSN	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1
898490	potassium citrate 15 MEQ Extended Release Oral Tablet	PSN	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1
603281	UROCIT-K 10 MEQ Extended Release Oral Tablet	PSN	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1
898517	UROCIT-K 15 MEQ Extended Release Oral Tablet	PSN	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1
603281	potassium citrate 10 MEQ Extended Release Oral Tablet [Urocit-K]	SBD	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1
898517	potassium citrate 15 MEQ Extended Release Oral Tablet [Urocit-K]	SBD	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1
199381	potassium citrate 10 MEQ Extended Release Oral Tablet	SCD	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1
898490	potassium citrate 15 MEQ Extended Release Oral Tablet	SCD	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1
199381	K+ citrate 10 MEQ Extended Release Oral Tablet	SY	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1
603281	K+ citrate 10 MEQ Extended Release Oral Tablet [Urocit-K]	SY	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1
898490	K+ citrate 15 MEQ Extended Release Oral Tablet	SY	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1
898517	K+ citrate 15 MEQ Extended Release Oral Tablet [Urocit-K]	SY	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1
199381	Pot citrate 10 MEQ Extended Release Oral Tablet	SY	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1
603281	Pot citrate 10 MEQ Extended Release Oral Tablet [Urocit-K]	SY	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1
898490	Pot citrate 15 MEQ Extended Release Oral Tablet	SY	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1
898517	Pot citrate 15 MEQ Extended Release Oral Tablet [Urocit-K]	SY	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1
199381	potassium citrate 1080 MG Extended Release Oral Tablet	SY	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1
898490	potassium citrate 1620 MG Extended Release Oral Tablet	SY	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1
603281	Urocit-K 10 MEQ Extended Release Oral Tablet	SY	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1
898517	Urocit-K 15 MEQ Extended Release Oral Tablet	SY	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1
898517	Urocit-K 1620 MG Extended Release Oral Tablet	SY	d2c923d5-85c1-4bbb-9f93-556080a5ef87	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0178-0615-01	00178061501	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0178-0615-01)	2010-01-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
UROCIT-K	Mission Pharmacal Company	2025-12-02	HUMAN PRESCRIPTION DRUG LABEL	28
UROCIT-K	Physicians Total Care, Inc.	2010-04-23	HUMAN PRESCRIPTION DRUG LABEL	1