FDA Orange Book
Generic for Urocit-k
Urocit-k contains potassium citrate. 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 Urocit-k is potassium citrate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Urocit-k products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 10MEQ | Marketed (Rx) | AB | 8 | AB |
| tablet, extended release, oral | 15MEQ | Marketed (Rx) | AB | 7 | AB |
| tablet, extended release, oral | 5MEQ | Marketed (Rx) | AB | 6 | AB |
NDA 019071, held by MISSION PHARMACAL CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic potassium citrate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RISING PHARMA HOLDINGS INC | 077440 | AB (A-rated, therapeutically equivalent) | June 8, 2006 | 10MEQ, 5MEQ |
| ZYDUS PHARMACEUTICALS USA INC | 203546 | AB (A-rated, therapeutically equivalent) | August 6, 2014 | 10MEQ, 15MEQ, 5MEQ |
| STRIDES PHARMA GLOBAL PTE LTD | 206813 | AB (A-rated, therapeutically equivalent) | September 11, 2017 | 10MEQ, 15MEQ, 5MEQ |
| TEVA PHARMACEUTICALS USA INC | 209758 | AB (A-rated, therapeutically equivalent) | March 5, 2018 | 10MEQ, 15MEQ, 5MEQ |
| ANI PHARMACEUTICALS INC | 212779 | AB (A-rated, therapeutically equivalent) | January 14, 2020 | 10MEQ, 15MEQ |
| BIONPHARMA INC | 212799 | AB (A-rated, therapeutically equivalent) | June 29, 2020 | 10MEQ, 15MEQ |
| ASCENT PHARMACEUTICALS INC | 214420 | AB (A-rated, therapeutically equivalent) | February 5, 2021 | 10MEQ, 15MEQ, 5MEQ |
| ADAPTIS PHARMA PRIVATE LTD | 214426 | AB (A-rated, therapeutically equivalent) | February 19, 2021 | 10MEQ, 15MEQ, 5MEQ |
Urocit-k NDC codes
Questions
Is there a generic for Urocit-k?
Yes. The generic name for Urocit-k is potassium citrate. 8 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 Urocit-k?
The active ingredient in Urocit-k is potassium citrate, 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.