FDA Orange Book
Generic for K-tab
K-tab 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 K-tab 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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K-tab 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 |
| tablet, extended release, oral | 20MEQ | Discontinued | None | 14 | AB1, AB3 |
| tablet, extended release, oral | 8MEQ | Discontinued | None | 10 | AB2 |
NDA 018279, held by ABBVIE 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, 20MEQ |
| ACTAVIS LABORATORIES FL INC | 075604 | AB1 (A-rated, therapeutically equivalent) | April 10, 2002 | 10MEQ, 20MEQ |
| PHARMOBEDIENT CONSULTING LLC | 204662 | AB2 (A-rated, therapeutically equivalent) | August 21, 2014 | 10MEQ, 8MEQ |
| PADAGIS US LLC | 205993 | AB2 (A-rated, therapeutically equivalent) | November 5, 2015 | 10MEQ, 8MEQ |
| NOVEL LABORATORIES INC | 206347 | AB1 (A-rated, therapeutically equivalent) | January 21, 2016 | 10MEQ, 20MEQ |
| NOVEL LABORATORIES INC | 206759 | AB2 (A-rated, therapeutically equivalent) | August 9, 2016 | 10MEQ, 8MEQ |
| TWI PHARMACEUTICALS INC | 209688 | AB3 (A-rated, therapeutically equivalent) | January 12, 2018 | 10MEQ, 20MEQ |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 209314 | AB2 (A-rated, therapeutically equivalent) | June 22, 2018 | 10MEQ, 8MEQ |
| STRIDES PHARMA GLOBAL PTE LTD | 210733 | AB2 (A-rated, therapeutically equivalent) | August 31, 2018 | 10MEQ, 8MEQ |
| AUROBINDO PHARMA LTD | 210921 | AB2 (A-rated, therapeutically equivalent) | December 19, 2018 | 10MEQ, 8MEQ |
| PRINSTON PHARMACEUTICAL INC | 209922 | AB1 (A-rated, therapeutically equivalent) | April 30, 2019 | 10MEQ, 20MEQ |
| ADARE PHARMACEUTICALS INC | 076368 | AB1 (A-rated, therapeutically equivalent) | June 5, 2019 | 10MEQ, 20MEQ |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 212561 | AB3 (A-rated, therapeutically equivalent) | September 30, 2019 | 10MEQ, 20MEQ |
| GRANULES PHARMACEUTICALS INC | 211797 | AB2 (A-rated, therapeutically equivalent) | March 4, 2020 | 10MEQ, 8MEQ |
| ZYDUS PHARMACEUTICALS USA INC | 210395 | AB1 (A-rated, therapeutically equivalent) | September 17, 2020 | 10MEQ, 20MEQ |
| GRANULES INDIA LTD | 214452 | AB1 (A-rated, therapeutically equivalent) | October 21, 2020 | 10MEQ, 20MEQ |
| ASCENT PHARMACEUTICALS INC | 214422 | AB1 (A-rated, therapeutically equivalent) | December 29, 2020 | 10MEQ, 20MEQ |
| GUANGZHOU NOVAKEN PHARM CO LTD | 214395 | AB1 (A-rated, therapeutically equivalent) | January 28, 2021 | 10MEQ, 20MEQ |
| RUBICON RESEARCH LTD | 215725 | AB3 (A-rated, therapeutically equivalent) | July 25, 2022 | 10MEQ, 20MEQ |
| RUBICON RESEARCH LTD | 216321 | AB1 (A-rated, therapeutically equivalent) | June 16, 2023 | 10MEQ, 20MEQ |
| RISING PHARMA HOLDINGS INC | 217412 | AB2 (A-rated, therapeutically equivalent) | December 19, 2023 | 10MEQ, 8MEQ |
| MACLEODS PHARMACEUTICALS LTD | 216269 | AB1 (A-rated, therapeutically equivalent) | May 9, 2024 | 10MEQ, 20MEQ |
| MACLEODS PHARMACEUTICALS LTD | 212987 | AB2 (A-rated, therapeutically equivalent) | September 6, 2024 | 10MEQ, 8MEQ |
| TWI PHARMACEUTICALS INC | 218979 | AB2 (A-rated, therapeutically equivalent) | October 28, 2024 | 10MEQ, 8MEQ |
Questions
Is there a generic for K-tab?
Yes. The generic name for K-tab 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 K-tab?
The active ingredient in K-tab 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.