Application 019123

Type: NDA
Sponsor: UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KLOR-CON	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	8MEQ	Yes	No
002	KLOR-CON	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MEQ	Yes	Yes

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

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
N019123-001	KLOR-CON	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17
N019123-002	KLOR-CON	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019123-001	AB2
N019123-002	AB2

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 · 82 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	N019123-001	KLOR-CON	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019123-002	KLOR-CON	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019123-001	KLOR-CON	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019123-002	KLOR-CON	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019123-001	KLOR-CON	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019123-002	KLOR-CON	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019123-001	KLOR-CON	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019123-002	KLOR-CON	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019123-001	KLOR-CON	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019123-002	KLOR-CON	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019123-001	KLOR-CON	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019123-002	KLOR-CON	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019123-001	KLOR-CON	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019123-002	KLOR-CON	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019123-001	KLOR-CON	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019123-002	KLOR-CON	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019123-001	KLOR-CON	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019123-002	KLOR-CON	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019123-001	KLOR-CON	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019123-002	KLOR-CON	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019123-001	KLOR-CON	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019123-002	KLOR-CON	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019123-001	KLOR-CON	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019123-002	KLOR-CON	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019123-001	KLOR-CON	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019123-002	KLOR-CON	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019123-001	KLOR-CON	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019123-002	KLOR-CON	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019123-001	KLOR-CON	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019123-002	KLOR-CON	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019123-001	KLOR-CON	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019123-002	KLOR-CON	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019123-001	KLOR-CON	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019123-002	KLOR-CON	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019123-001	KLOR-CON	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019123-002	KLOR-CON	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019123-001	KLOR-CON	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019123-002	KLOR-CON	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019123-001	KLOR-CON	8MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD	1986-04-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019123-002	KLOR-CON	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB2	RLD, RS	1986-04-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	N019123-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019123-002	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019123-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019123-002	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019123-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019123-002	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019123-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019123-002	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019123-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019123-002	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019123-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019123-002	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019123-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019123-002	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019123-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019123-002	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019123-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019123-002	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019123-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019123-002	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019123-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019123-002	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019123-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019123-002	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019123-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019123-002	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019123-001	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019123-002	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019123-001	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019123-002	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019123-001	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019123-002	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019123-001	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019123-002	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019123-001	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019123-002	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019123-001	AB2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019123-002	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019123-001	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019123-002	AB2	1	`782e0a99824c…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	Northwind Health Company, LLC	f2b671c9-9874-2668-e053-2a95a90a1b46	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019123 application number: NDA019123
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	8f6ea056-5e10-4de1-97f0-55f0655a6f78	2025-08-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019123 application number: NDA019123
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	8757d093-747b-4e97-af6d-4064b16178b2	2025-08-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019123 application number: NDA019123
Potassium Chloride	POTASSIUM CHLORIDE	AvKARE	8bb030b7-104a-373b-e053-2995a90ab580	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019123 application number: NDA019123
Potassium Chloride	POTASSIUM CHLORIDE	Upsher-Smith Laboratories, LLC	616f0de7-8843-44a1-8fa6-274d889286aa	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019123 application number: NDA019123
KLOR-CON	POTASSIUM CHLORIDE	Upsher-Smith Laboratories, LLC	1ff53330-065c-4213-9c0c-ac498621d09d	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019123 application number: NDA019123
Potassium Chloride	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	81a53ecd-2612-4efe-9491-415fff3f86e5	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019123 application number: NDA019123 ndc (product): 71610-349

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 84 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71335-0763	Potassium Chloride	Potassium Chloride	Bryant Ranch Prepack	NDA	Current
71335-0763	Potassium Chloride	Potassium Chloride	Bryant Ranch Prepack	NDA	Current
71610-349	Potassium Chloride	Potassium Chloride	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
71610-349	Potassium Chloride	Potassium Chloride	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53989	SUPPL	2018-05-03
53980	SUPPL	2018-05-02
52716	SUPPL	2018-02-26
40875	ORIG	2010-03-16
16199	SUPPL	2006-04-20
16198	SUPPL	2004-05-27
1230	SUPPL	2003-11-25