FDA Orange Book
Generic for Micro-k
Micro-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 Micro-k is potassium chloride. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Micro-k products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 10MEQ | Discontinued | None | 7 | AB |
| capsule, extended release, oral | 8MEQ | Discontinued | None | 6 | AB |
NDA 018238, held by NESHER PHARMACEUTICALS USA LLC. 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 |
|---|---|---|---|---|
| ACTAVIS LABORATORIES FL INC | 077419 | AB (A-rated, therapeutically equivalent) | June 2, 2008 | 10MEQ, 8MEQ |
| AMNEAL PHARMACEUTICALS | 202128 | AB (A-rated, therapeutically equivalent) | February 22, 2013 | 10MEQ |
| NOVEL LABORATORIES INC | 204828 | AB (A-rated, therapeutically equivalent) | August 16, 2016 | 10MEQ, 8MEQ |
| ADARE PHARMACEUTICALS INC | 208864 | AB (A-rated, therapeutically equivalent) | March 17, 2017 | 10MEQ, 8MEQ |
| ZYDUS PHARMACEUTICALS USA INC | 208445 | AB (A-rated, therapeutically equivalent) | March 11, 2019 | 10MEQ, 8MEQ |
| PRINSTON PHARMACEUTICAL INC | 209026 | AB (A-rated, therapeutically equivalent) | June 11, 2019 | 10MEQ, 8MEQ |
| GRANULES INDIA LTD | 214686 | AB (A-rated, therapeutically equivalent) | February 16, 2021 | 10MEQ, 8MEQ |
Questions
Is there a generic for Micro-k?
Yes. The generic name for Micro-k is potassium chloride. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Micro-k?
The active ingredient in Micro-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.