FDA Orange Book
Generic for Slow-k
Slow-k 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 Slow-k is potassium chloride. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB2.
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Slow-k products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 8MEQ | Discontinued | None | 10 | AB2 |
NDA 017476, held by NOVARTIS PHARMACEUTICALS CORP. 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 |
|---|---|---|---|---|
| PHARMOBEDIENT CONSULTING LLC | 204662 | AB2 (A-rated, therapeutically equivalent) | August 21, 2014 | 8MEQ |
| PADAGIS US LLC | 205993 | AB2 (A-rated, therapeutically equivalent) | November 5, 2015 | 8MEQ |
| NOVEL LABORATORIES INC | 206759 | AB2 (A-rated, therapeutically equivalent) | August 9, 2016 | 8MEQ |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 209314 | AB2 (A-rated, therapeutically equivalent) | June 22, 2018 | 8MEQ |
| STRIDES PHARMA GLOBAL PTE LTD | 210733 | AB2 (A-rated, therapeutically equivalent) | August 31, 2018 | 8MEQ |
| AUROBINDO PHARMA LTD | 210921 | AB2 (A-rated, therapeutically equivalent) | December 19, 2018 | 8MEQ |
| GRANULES PHARMACEUTICALS INC | 211797 | AB2 (A-rated, therapeutically equivalent) | March 4, 2020 | 8MEQ |
| RISING PHARMA HOLDINGS INC | 217412 | AB2 (A-rated, therapeutically equivalent) | December 19, 2023 | 8MEQ |
| MACLEODS PHARMACEUTICALS LTD | 212987 | AB2 (A-rated, therapeutically equivalent) | September 6, 2024 | 8MEQ |
| TWI PHARMACEUTICALS INC | 218979 | AB2 (A-rated, therapeutically equivalent) | October 28, 2024 | 8MEQ |
Questions
Is there a generic for Slow-k?
Yes. The generic name for Slow-k is potassium chloride. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB2.
What is the generic name for Slow-k?
The active ingredient in Slow-k 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.