Application 074726

Type: ANDA
Sponsor: UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KLOR-CON M20	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	20MEQ	No	Yes
002	KLOR-CON M10	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MEQ	No	No
003	KLOR-CON M15	POTASSIUM CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	15MEQ	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A074726-001	KLOR-CON M20	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	1998-11-20
A074726-002	KLOR-CON M10	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2000-08-09
A074726-003	KLOR-CON M15	POTASSIUM CHLORIDE	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2003-06-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074726-001	AB1
A074726-002	AB1
A074726-003	AB1

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 · 129 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
2026-09-14 22:38:34	2026-08	A074726-001	KLOR-CON M20	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	1998-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074726-002	KLOR-CON M10	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2000-08-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074726-003	KLOR-CON M15	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2003-06-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074726-001	KLOR-CON M20	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	1998-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074726-002	KLOR-CON M10	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2000-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074726-003	KLOR-CON M15	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2003-06-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074726-001	KLOR-CON M20	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	1998-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074726-002	KLOR-CON M10	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2000-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074726-003	KLOR-CON M15	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2003-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074726-001	KLOR-CON M20	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	1998-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074726-002	KLOR-CON M10	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2000-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074726-003	KLOR-CON M15	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2003-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074726-001	KLOR-CON M20	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	1998-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074726-002	KLOR-CON M10	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2000-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074726-003	KLOR-CON M15	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2003-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074726-001	KLOR-CON M20	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	1998-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074726-002	KLOR-CON M10	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2000-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074726-003	KLOR-CON M15	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2003-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074726-001	KLOR-CON M20	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	1998-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074726-002	KLOR-CON M10	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2000-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074726-003	KLOR-CON M15	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2003-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074726-001	KLOR-CON M20	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	1998-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074726-002	KLOR-CON M10	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2000-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074726-003	KLOR-CON M15	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2003-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074726-001	KLOR-CON M20	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	1998-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074726-002	KLOR-CON M10	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2000-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074726-003	KLOR-CON M15	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2003-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074726-001	KLOR-CON M20	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	1998-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074726-002	KLOR-CON M10	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2000-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074726-003	KLOR-CON M15	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2003-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074726-001	KLOR-CON M20	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	1998-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074726-002	KLOR-CON M10	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2000-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074726-003	KLOR-CON M15	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2003-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074726-001	KLOR-CON M20	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	1998-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074726-002	KLOR-CON M10	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2000-08-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074726-003	KLOR-CON M15	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2003-06-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074726-001	KLOR-CON M20	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	1998-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074726-002	KLOR-CON M10	10MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2000-08-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074726-003	KLOR-CON M15	15MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1		2003-06-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074726-001	KLOR-CON M20	20MEQ	TABLET, EXTENDED RELEASE / ORAL	AB1	RS	1998-11-20	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A074726-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074726-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074726-003	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074726-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074726-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074726-003	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074726-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074726-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074726-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074726-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074726-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074726-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074726-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074726-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074726-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074726-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074726-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074726-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074726-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074726-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074726-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074726-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074726-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074726-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074726-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074726-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074726-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074726-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074726-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074726-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074726-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074726-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074726-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074726-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074726-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074726-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074726-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074726-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074726-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074726-001	AB1	1	`301d65b070ca…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	Redpharm Drug	5261dfe5-d62b-d618-e063-6294a90a96e7	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074726 application number: ANDA074726
Potassium Chloride	POTASSIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d2e84d34-e042-477f-9944-3fcb95301217	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074726 application number: ANDA074726 ndc (product): 71610-343
Potassium Chloride	POTASSIUM CHLORIDE	Northwind Health Company, LLC	dae7c63d-eef0-58d0-e053-2a95a90a667e	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074726 application number: ANDA074726
Potassium Chloride	POTASSIUM CHLORIDE	Northwind Health Company, LLC	0a72cc27-e092-d85a-e063-6294a90a503c	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074726 application number: ANDA074726
KLOR-CON M	POTASSIUM CHLORIDE	Cardinal Health 107, LLC	ee3a1815-7325-4838-9764-fe1db68877b6	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074726 application number: ANDA074726
Potassium Chloride	POTASSIUM CHLORIDE	Bryant Ranch Prepack	0e875691-7372-46ac-80a1-946e08b40061	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074726 application number: ANDA074726 ndc (product): 71335-1747
Potassium Chloride	POTASSIUM CHLORIDE	AvKARE	8baf3f25-c78b-6c08-e053-2995a90a667e	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074726 application number: ANDA074726
KLOR-CON M	POTASSIUM CHLORIDE	Upsher-Smith Laboratories, LLC	b89910f6-4ff5-4a62-8269-696f7c10e4f6	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074726 application number: ANDA074726
Potassium Chloride	POTASSIUM CHLORIDE	Upsher-SmithLaboratories, LLC	ad584ce4-a64d-4851-80e9-0eeedc0b9d06	2025-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074726 application number: ANDA074726
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	5c4b0be5-625e-435f-9d2c-9d8fb407a8ea	2023-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074726 application number: ANDA074726
Potassium Chloride	POTASSIUM CHLORIDE	A-S Medication Solutions	d033c3b3-3ed6-4f23-a555-bae40cf0c48f	2023-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074726 application number: ANDA074726

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 110 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66758-180	KLOR-CON M	potassium chloride	Sandoz Inc.	ANDA	Current
66758-180	KLOR-CON M	potassium chloride	Sandoz Inc.	ANDA	Current
66758-180	KLOR-CON M	potassium chloride	Sandoz Inc.	ANDA	Current
66758-190	KLOR-CON M	potassium chloride	Sandoz Inc.	ANDA	Current
66758-190	KLOR-CON M	potassium chloride	Sandoz Inc.	ANDA	Current
66758-190	KLOR-CON M	potassium chloride	Sandoz Inc.	ANDA	Current
67046-588	Potassium Chloride	Potassium Chloride	Contract Pharmacy Services-PA	ANDA	Current
67046-590	Potassium Chloride	Potassium Chloride	Contract Pharmacy Services-PA	ANDA	Current
67544-349	Klor-Con M	Potassium Chloride	Aphena Pharma Solutions - Tennessee, Inc.	ANDA	Current
70518-0152	Potassium Chloride	Potassium Chloride	REMEDYREPACK INC.	ANDA	Current
70518-0152	Potassium Chloride	Potassium Chloride	REMEDYREPACK INC.	ANDA	Current
70518-1899	KLOR-CON M	potassium chloride	REMEDYREPACK INC.	ANDA	Current
70518-2558	KLOR-CON M	potassium chloride	REMEDYREPACK INC.	ANDA	Current
70518-2558	KLOR-CON M	potassium chloride	REMEDYREPACK INC.	ANDA	Current
70518-2592	Potassium Chloride	potassium chloride	REMEDYREPACK INC.	ANDA	Current
70518-2592	Potassium Chloride	potassium chloride	REMEDYREPACK INC.	ANDA	Current
70518-2882	Potassium Chloride	potassium chloride	REMEDYREPACK INC.	ANDA	Current
70518-2882	Potassium Chloride	potassium chloride	REMEDYREPACK INC.	ANDA	Current
70934-283	Potassium Chloride	Potassium Chloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-283	Potassium Chloride	Potassium Chloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-923	Potassium Chloride	potassium chloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-923	Potassium Chloride	potassium chloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-1747	Potassium Chloride	potassium chloride	Bryant Ranch Prepack	ANDA	Current
71610-343	Potassium Chloride	potassium chloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-343	Potassium Chloride	potassium chloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-343	Potassium Chloride	potassium chloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72789-001	Potassium Chloride	Potassium Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-001	Potassium Chloride	Potassium Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-001	Potassium Chloride	Potassium Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-001	Potassium Chloride	Potassium Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42864	SUPPL	2016-02-03
42863	SUPPL	2016-02-03
42862	SUPPL	2016-02-03
22355	SUPPL	2016-02-03
18363	ORIG	2004-06-07
22354	ORIG	2003-08-01
8437	ORIG	1998-11-20