FDA Orange Book · active-ingredient family
Potassium chloride
Potassium chloride is approved as 14 brand and 117 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:POKONZA · NDA 206814
14
Brand (NDA)
117
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release, for solution, for suspension, extended release, injectable, solution, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| POKONZARLD×3 | GENUS LIFESCIENCES | NDA 206814 | — | Nov 25, 2025 | |
| POKONZARLD×4 | GENUS | NDA 208019 | — | Aug 25, 2023 | |
| POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINERRLD×6 | OTSUKA ICU MEDCL | NDA 020161 | AP | Nov 30, 1992 | |
| POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINERRLD×6 | BAXTER HLTHCARE | NDA 019904 | AP | Dec 26, 1989 | |
| MICRO-K LSRLD | KV PHARM | NDA 019561 | — | Aug 26, 1988 | |
| K-TABRLD×3 | ABBVIE | NDA 018279 | — | Aug 01, 1988 | |
| POTASSIUM CHLORIDERLD×2 | SCHERING | NDA 019439 | — | Jun 13, 1986 | |
| KLOR-CONRLD×2 | UPSHER SMITH LABS | NDA 019123 | AB2 | Apr 17, 1986 | |
| MICRO-KRLD×2 | NESHER PHARMS | NDA 018238 | — | Approved Prior to Jan 1, 1982 | |
| TEN-K | NOVARTIS | NDA 019381 | — | Apr 16, 1986 | |
| POTASSIUM CHLORIDE | LILLY | NDA 007865 | — | Approved Prior to Jan 1, 1982 | |
| KAON CL×2 | SAVAGE LABS | NDA 017046 | — | Approved Prior to Jan 1, 1982 | |
| KLOTRIX | APOTHECON | NDA 017850 | — | Approved Prior to Jan 1, 1982 | |
| SLOW-K | NOVARTIS | NDA 017476 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (117)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| POTASSIUM CHLORIDE×2 | QUAGEN | ANDA 215716 | AA | Dec 22, 2025 | |
| POTASSIUM CHLORIDE×2 | AUROBINDO PHARMA | ANDA 216536 | AA | Nov 20, 2025 | |
| POTASSIUM CHLORIDE×2 | MACLEODS PHARMS LTD | ANDA 218733 | AA | Sep 10, 2025 | |
| POTASSIUM CHLORIDE | TARO | ANDA 218960 | AA | Jul 22, 2025 | |
| POTASSIUM CHLORIDE | ANDA REPOSITORY | ANDA 219009 | AA | Jul 11, 2025 | |
| POTASSIUM CHLORIDE×2 | ASCENT PHARMS INC | ANDA 211992 | AA | Apr 09, 2025 | |
| POTASSIUM CHLORIDE×2 | TWI PHARMS | ANDA 218979 | AB2 | Oct 28, 2024 | |
| POTASSIUM CHLORIDE×2 | MACLEODS PHARMS LTD | ANDA 212987 | AB2 | Sep 06, 2024 | |
| POTASSIUM CHLORIDE×3 | MACLEODS PHARMS LTD | ANDA 216269 | AB1 | May 09, 2024 | |
| POTASSIUM CHLORIDE×2 | STRIDES PHARMA | ANDA 211665 | AA | Jan 16, 2024 | |
| POTASSIUM CHLORIDE×2 | RISING | ANDA 217412 | AB2 | Dec 19, 2023 | |
| POTASSIUM CHLORIDE | NEXUS | ANDA 217704 | AP | Aug 14, 2023 | |
| POTASSIUM CHLORIDE | NOVITIUM PHARMA | ANDA 212816 | AA | Jul 12, 2023 | |
| POTASSIUM CHLORIDE×3 | RUBICON RESEARCH | ANDA 216321 | AB1 | Jun 16, 2023 | |
| POTASSIUM CHLORIDE×2 | AJENAT PHARMS | ANDA 216156 | AA | Mar 07, 2023 | |
| POTASSIUM CHLORIDE×2 | ANDA REPOSITORY | ANDA 214892 | AA | Dec 30, 2022 | |
| POTASSIUM CHLORIDE×3 | RUBICON RESEARCH | ANDA 215725 | AB3 | Jul 25, 2022 | |
| POTASSIUM CHLORIDE×2 | WES PHARMA INC | ANDA 213062 | AA | Jun 06, 2022 | |
| POTASSIUM CHLORIDE | RUBICON RESEARCH | ANDA 214108 | AA | Mar 24, 2022 | |
| POTASSIUM CHLORIDE | GRANULES | ANDA 213467 | AA | Jan 27, 2022 | |
| POTASSIUM CHLORIDE×2 | TRIS PHARMA INC | ANDA 214076 | — | Jan 26, 2022 | |
| POTASSIUM CHLORIDE×2 | RUBICON RESEARCH | ANDA 214656 | AA | Jan 13, 2022 | |
| POTASSIUM CHLORIDE×2 | SCIEGEN PHARMS | ANDA 211648 | AA | May 21, 2021 | |
| POTASSIUM CHLORIDE×3 | AUROBINDO PHARMA LTD | ANDA 214728 | — | Mar 31, 2021 | |
| POTASSIUM CHLORIDE 10MEQ×5 | NEXUS | ANDA 214727 | AP | Mar 18, 2021 | |
| POTASSIUM CHLORIDE | STRIDES PHARMA | ANDA 211667 | AA | Mar 11, 2021 | |
| POTASSIUM CHLORIDE×2 | GRANULES | ANDA 214686 | AB | Feb 16, 2021 | |
| POTASSIUM CHLORIDE×2 | GRANULES | ANDA 213392 | AA | Jan 29, 2021 | |
| POTASSIUM CHLORIDE×2 | GUANGZHOU NOVAKEN | ANDA 214395 | AB1 | Jan 28, 2021 | |
| POTASSIUM CHLORIDE×3 | ASCENT PHARMS INC | ANDA 214422 | AB1 | Dec 29, 2020 | |
| POTASSIUM CHLORIDE×2 | GRANULES | ANDA 214452 | AB1 | Oct 21, 2020 | |
| POTASSIUM CHLORIDE×2 | ZYDUS PHARMS | ANDA 210395 | AB1 | Sep 17, 2020 | |
| POTASSIUM CHLORIDE 10MEQ×5 | FRESENIUS KABI USA | ANDA 211087 | AP | Sep 09, 2020 | |
| POTASSIUM CHLORIDE×2 | BRECKENRIDGE | ANDA 213588 | — | Aug 21, 2020 | |
| POTASSIUM CHLORIDE×3 | AMNEAL | ANDA 212861 | — | May 08, 2020 | |
| POTASSIUM CHLORIDE×2 | GRANULES | ANDA 211797 | AB2 | Mar 04, 2020 | |
| POTASSIUM CHLORIDE×2 | YICHANG HUMANWELL | ANDA 212561 | AB3 | Sep 30, 2019 | |
| POTASSIUM CHLORIDE | STRIDES PHARMA | ANDA 210097 | — | Jun 17, 2019 | |
| POTASSIUM CHLORIDE×2 | PRINSTON INC | ANDA 209026 | AB | Jun 11, 2019 | |
| POTASSIUM CHLORIDE×2 | ADARE PHARMS INC | ANDA 076368 | AB1 | Jun 05, 2019 | |
| POTASSIUM CHLORIDE | AMNEAL | ANDA 210902 | AA | May 23, 2019 | |
| POTASSIUM CHLORIDE | AJENAT PHARMS | ANDA 212183 | AA | May 06, 2019 | |
| POTASSIUM CHLORIDE×3 | PRINSTON INC | ANDA 209922 | AB1 | Apr 30, 2019 | |
| POTASSIUM CHLORIDE | CHARTWELL RX | ANDA 210098 | — | Apr 26, 2019 | |
| POTASSIUM CHLORIDE×2 | PHARM ASSOC | ANDA 210766 | AA | Mar 29, 2019 | |
| POTASSIUM CHLORIDE×3 | CHARTWELL RX | ANDA 206630 | — | Mar 29, 2019 | |
| POTASSIUM CHLORIDE×2 | ZYDUS PHARMS | ANDA 208445 | AB | Mar 11, 2019 | |
| POTASSIUM CHLORIDE×2 | STRIDES PHARMA | ANDA 206881 | — | Jan 22, 2019 | |
| POTASSIUM CHLORIDE×2 | AUROBINDO PHARMA | ANDA 210921 | AB2 | Dec 19, 2018 | |
| POTASSIUM CHLORIDE | EPIC PHARMA LLC | ANDA 210200 | AA | Nov 23, 2018 | |
| POTASSIUM CHLORIDE | NOVEL LABS INC | ANDA 210241 | AA | Nov 21, 2018 | |
| POTASSIUM CHLORIDE×2 | STRIDES PHARMA | ANDA 210733 | AB2 | Aug 31, 2018 | |
| POTASSIUM CHLORIDE×2 | NOVEL LABS INC | ANDA 209786 | AA | Aug 29, 2018 | |
| POTASSIUM CHLORIDE×2 | APOTEX | ANDA 211067 | — | Aug 08, 2018 | |
| POTASSIUM CHLORIDE×2 | AMNEAL | ANDA 210041 | AA | Jul 19, 2018 | |
| POTASSIUM CHLORIDE×2 | YICHANG HUMANWELL | ANDA 209314 | AB2 | Jun 22, 2018 | |
| POTASSIUM CHLORIDE×2 | TWI PHARMS | ANDA 209688 | AB3 | Jan 12, 2018 | |
| KLOR-CON | UPSHER SMITH LABS | ANDA 209662 | AA | Oct 23, 2017 | |
| POTASSIUM CHLORIDE×2 | ADARE PHARMS INC | ANDA 208864 | AB | Mar 17, 2017 | |
| POTASSIUM CHLORIDE×2 | SIGMAPHARM LABS LLC | ANDA 207528 | — | Aug 19, 2016 | |
| POTASSIUM CHLORIDE×2 | NOVEL LABS INC | ANDA 204828 | AB | Aug 16, 2016 | |
| POTASSIUM CHLORIDE×2 | NOVEL LABS INC | ANDA 206759 | AB2 | Aug 09, 2016 | |
| POTASSIUM CHLORIDE×2 | GLENMARK PHARMS LTD | ANDA 203562 | AB1 | Jul 26, 2016 | |
| POTASSIUM CHLORIDE×2 | CHARTWELL MOLECULAR | ANDA 204210 | — | Mar 28, 2016 | |
| POTASSIUM CHLORIDE×2 | TRIS PHARMA INC | ANDA 201944 | — | Mar 04, 2016 | |
| POTASSIUM CHLORIDE×2 | NOVEL LABS INC | ANDA 206347 | AB1 | Jan 21, 2016 | |
| POTASSIUM CHLORIDE | GLENMARK PHARMS LTD | ANDA 202868 | — | Jan 19, 2016 | |
| POTASSIUM CHLORIDE×2 | LUPIN | ANDA 203002 | — | Dec 18, 2015 | |
| POTASSIUM CHLORIDE×2 | STRIDES PHARMA | ANDA 205549 | — | Dec 08, 2015 | |
| POTASSIUM CHLORIDE×2 | PADAGIS US | ANDA 205993 | AB2 | Nov 05, 2015 | |
| KLOR-CON×2 | UPSHER SMITH LABS | ANDA 203106 | — | Jul 10, 2015 | |
| POTASSIUM CHLORIDE×2 | PHARMOBEDIENT | ANDA 204662 | AB2 | Aug 21, 2014 | |
| POTASSIUM CHLORIDE×2 | PH HEALTH | ANDA 202886 | — | Dec 26, 2013 | |
| POTASSIUM CHLORIDE | AMNEAL PHARMS | ANDA 202128 | AB | Feb 22, 2013 | |
| POTASSIUM CHLORIDE×2 | PADAGIS US | ANDA 200185 | — | May 18, 2011 | |
| POTASSIUM CHLORIDE×2 | ACTAVIS LABS FL INC | ANDA 077419 | AB | Jun 02, 2008 | |
| POTASSIUM CHLORIDE×2 | ACTAVIS LABS FL INC | ANDA 075604 | AB1 | Apr 10, 2002 | |
| POTASSIUM CHLORIDE | NESHER PHARMS | ANDA 076044 | — | Apr 05, 2002 | |
| KLOR-CON M10×3 | UPSHER SMITH LABS | ANDA 074726 | AB1 | Aug 09, 2000 | |
| POTASSIUM CHLORIDE | TEVA | ANDA 073531 | — | Apr 26, 1996 | |
| POTASSIUM CHLORIDE | TEVA | ANDA 073532 | — | Apr 26, 1996 | |
| K+8 | FUTURE PAK | ANDA 070998 | — | Jan 25, 1993 | |
| K-LEASE | SAVAGE LABS | ANDA 073398 | — | Jan 28, 1992 | |
| K-LEASE | SAVAGE LABS | ANDA 072427 | — | Mar 28, 1990 | |
| POTASSIUM CHLORIDE | WATSON LABS | ANDA 089163 | — | Mar 10, 1988 | |
| K+10 | FUTURE PAK | ANDA 070999 | — | Oct 22, 1987 | |
| POTASSIUM CHLORIDE | COPLEY PHARM | ANDA 070618 | — | Sep 09, 1987 | |
| POTASSIUM CHLORIDE | NESHER PHARMS | ANDA 070980 | — | Feb 17, 1987 | |
| POTASSIUM CHLORIDE | WATSON LABS | ANDA 089421 | — | Jan 02, 1987 | |
| POTASSIUM CHLORIDE | EPIC PHARMA LLC | ANDA 088286 | — | Sep 05, 1985 | |
| POTASSIUM CHLORIDE IN PLASTIC CONTAINER | FRESENIUS KABI USA | ANDA 088901 | AP | Jan 25, 1985 | |
| POTASSIUM CHLORIDE IN PLASTIC CONTAINER | FRESENIUS KABI USA | ANDA 088908 | AP | Jan 25, 1985 | |
| POTASSIUM CHLORIDE | PHARMA SERVE NY | ANDA 087362 | — | Mar 08, 1983 | |
| POTASSIUM CHLORIDE | ABRAXIS PHARM | ANDA 087885 | — | Feb 03, 1983 | |
| POTASSIUM CHLORIDE | FRESENIUS KABI USA | ANDA 087817 | — | Oct 20, 1982 | |
| POTASSIUM CHLORIDE | ABRAXIS PHARM | ANDA 087787 | — | Apr 20, 1982 | |
| POTASSIUM CHLORIDERLD | ABRAXIS PHARM | ANDA 080204 | — | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDE | ABRAXIS PHARM | ANDA 084290 | — | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDE | ABRAXIS PHARM | ANDA 086713 | — | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDE | ABRAXIS PHARM | ANDA 086714 | — | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDE | B BRAUN | ANDA 085870 | AP | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDE | BAXTER HLTHCARE | ANDA 080203 | — | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDE | BAXTER HLTHCARE | ANDA 085499 | — | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDERLD×2 | FRESENIUS KABI USA | ANDA 080225 | — | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDE×4 | GD SEARLE LLC | ANDA 086219 | — | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDE×2 | GD SEARLE LLC | ANDA 086220 | — | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDERLD×4 | HOSPIRA | ANDA 080205 | AP | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDE×3 | HOSPIRA | ANDA 083345 | — | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDE | INTL MEDICATION | ANDA 083163 | — | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDE | LUITPOLD | ANDA 080221 | — | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDE | LUITPOLD | ANDA 080736 | — | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDE | LUITPOLD | ANDA 087584 | — | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDE | LUITPOLD | ANDA 087585 | — | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDE×4 | MILES | ANDA 080195 | — | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDE | PHARMA SERVE NY | ANDA 086297 | — | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDE | WATSON LABS | ANDA 086208 | — | Approved Prior to Jan 1, 1982 | |
| POTASSIUM CHLORIDE | WATSON LABS | ANDA 086210 | — | Approved Prior to Jan 1, 1982 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12539314 | Mar 07, 2039 | in 12 yr 11 mo | Product |
Potassium chloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
