FDA Orange Book
Generic for Kaon Cl-10
Kaon Cl-10 contains potassium chloride. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Kaon Cl-10 is potassium chloride. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2, AB3.
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Kaon Cl-10 products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 10MEQ | Discontinued | None | 24 | AB1, AB2, AB3 |
NDA 017046, held by SAVAGE LABORATORIES INC DIV ALTANA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic potassium chloride
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| UPSHER SMITH LABORATORIES LLC | 074726 | AB1 (A-rated, therapeutically equivalent) | August 9, 2000 | 10MEQ |
| ACTAVIS LABORATORIES FL INC | 075604 | AB1 (A-rated, therapeutically equivalent) | April 10, 2002 | 10MEQ |
| PHARMOBEDIENT CONSULTING LLC | 204662 | AB2 (A-rated, therapeutically equivalent) | August 21, 2014 | 10MEQ |
| PADAGIS US LLC | 205993 | AB2 (A-rated, therapeutically equivalent) | November 5, 2015 | 10MEQ |
| NOVEL LABORATORIES INC | 206347 | AB1 (A-rated, therapeutically equivalent) | January 21, 2016 | 10MEQ |
| NOVEL LABORATORIES INC | 206759 | AB2 (A-rated, therapeutically equivalent) | August 9, 2016 | 10MEQ |
| TWI PHARMACEUTICALS INC | 209688 | AB3 (A-rated, therapeutically equivalent) | January 12, 2018 | 10MEQ |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 209314 | AB2 (A-rated, therapeutically equivalent) | June 22, 2018 | 10MEQ |
| STRIDES PHARMA GLOBAL PTE LTD | 210733 | AB2 (A-rated, therapeutically equivalent) | August 31, 2018 | 10MEQ |
| AUROBINDO PHARMA LTD | 210921 | AB2 (A-rated, therapeutically equivalent) | December 19, 2018 | 10MEQ |
| PRINSTON PHARMACEUTICAL INC | 209922 | AB1 (A-rated, therapeutically equivalent) | April 30, 2019 | 10MEQ |
| ADARE PHARMACEUTICALS INC | 076368 | AB1 (A-rated, therapeutically equivalent) | June 5, 2019 | 10MEQ |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 212561 | AB3 (A-rated, therapeutically equivalent) | September 30, 2019 | 10MEQ |
| GRANULES PHARMACEUTICALS INC | 211797 | AB2 (A-rated, therapeutically equivalent) | March 4, 2020 | 10MEQ |
| ZYDUS PHARMACEUTICALS USA INC | 210395 | AB1 (A-rated, therapeutically equivalent) | September 17, 2020 | 10MEQ |
| GRANULES INDIA LTD | 214452 | AB1 (A-rated, therapeutically equivalent) | October 21, 2020 | 10MEQ |
| ASCENT PHARMACEUTICALS INC | 214422 | AB1 (A-rated, therapeutically equivalent) | December 29, 2020 | 10MEQ |
| GUANGZHOU NOVAKEN PHARM CO LTD | 214395 | AB1 (A-rated, therapeutically equivalent) | January 28, 2021 | 10MEQ |
| RUBICON RESEARCH LTD | 215725 | AB3 (A-rated, therapeutically equivalent) | July 25, 2022 | 10MEQ |
| RUBICON RESEARCH LTD | 216321 | AB1 (A-rated, therapeutically equivalent) | June 16, 2023 | 10MEQ |
| RISING PHARMA HOLDINGS INC | 217412 | AB2 (A-rated, therapeutically equivalent) | December 19, 2023 | 10MEQ |
| MACLEODS PHARMACEUTICALS LTD | 216269 | AB1 (A-rated, therapeutically equivalent) | May 9, 2024 | 10MEQ |
| MACLEODS PHARMACEUTICALS LTD | 212987 | AB2 (A-rated, therapeutically equivalent) | September 6, 2024 | 10MEQ |
| TWI PHARMACEUTICALS INC | 218979 | AB2 (A-rated, therapeutically equivalent) | October 28, 2024 | 10MEQ |
Questions
Is there a generic for Kaon Cl-10?
Yes. The generic name for Kaon Cl-10 is potassium chloride. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2, AB3.
What is the generic name for Kaon Cl-10?
The active ingredient in Kaon Cl-10 is potassium chloride, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.