Application 019071

Type: NDA
Sponsor: MISSION PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	UROCIT-K	POTASSIUM CITRATE	TABLET, EXTENDED RELEASE;ORAL	5MEQ	Yes	No
002	UROCIT-K	POTASSIUM CITRATE	TABLET, EXTENDED RELEASE;ORAL	10MEQ	Yes	No
003	UROCIT-K	POTASSIUM CITRATE	TABLET, EXTENDED RELEASE;ORAL	15MEQ	Yes	Yes

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 ndc (product): 44523-415
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 ndc (product): 0245-0071
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): 0178-0600 ndc (product): 0178-0610 ndc (product): 0178-0615

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 56 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0245-0070	Potassium Citrate	potassium citrate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0070	Potassium Citrate	potassium citrate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0070	Potassium Citrate	potassium citrate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0071	Potassium Citrate	potassium citrate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0071	Potassium Citrate	potassium citrate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0071	Potassium Citrate	potassium citrate	Upsher-Smith Laboratories, LLC	NDA	Current
44523-415	Potassium Citrate	potassium citrate	Biocomp Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
44523-415	Potassium Citrate	potassium citrate	Biocomp Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
44523-415	Potassium Citrate	potassium citrate	Biocomp Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
44523-415	Potassium Citrate	potassium citrate	Biocomp Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
70518-0086	UROCIT-K	potassium citrate	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69576	SUPPL	2021-12-16
69550	SUPPL	2021-12-14
16186	SUPPL	2010-01-08
11432	SUPPL	2010-01-08