FDA Orange Book
Generic for Suprep Bowel Prep Kit
Suprep Bowel Prep Kit contains sodium sulfate, potassium sulfate and magnesium sulfate. 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 Suprep Bowel Prep Kit is sodium sulfate, potassium sulfate and magnesium sulfate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Suprep Bowel Prep Kit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT | Marketed (Rx) | AA | 8 | AA |
NDA 022372, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sodium sulfate, potassium sulfate and magnesium sulfate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NOVEL LABORATORIES INC | 202511 | AA (A-rated, therapeutically equivalent) | February 23, 2017 | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT |
| STRIDES PHARMA INTERNATIONAL AG | 215469 | AA (A-rated, therapeutically equivalent) | November 22, 2023 | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT |
| ALKEM LABORATORIES LTD | 213924 | AA (A-rated, therapeutically equivalent) | December 29, 2023 | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 206431 | AA (A-rated, therapeutically equivalent) | March 19, 2024 | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT |
| BIONPHARMA INC | 204135 | AA (A-rated, therapeutically equivalent) | June 24, 2024 | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT |
| PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC AND DBA PAI PHARMA | 209941 | AA (A-rated, therapeutically equivalent) | July 15, 2024 | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT |
| ANNORA PHARMA PRIVATE LTD | 212903 | AA (A-rated, therapeutically equivalent) | October 18, 2024 | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT |
| MACLEODS PHARMACEUTICALS LTD | 219429 | AA (A-rated, therapeutically equivalent) | August 31, 2026 | 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT |
Suprep Bowel Prep Kit exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-315 | Orphan drug exclusivity | August 5, 2027 | 022372 |
Suprep Bowel Prep Kit NDC codes
Questions
Is there a generic for Suprep Bowel Prep Kit?
Yes. The generic name for Suprep Bowel Prep Kit is sodium sulfate, potassium sulfate and magnesium sulfate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Suprep Bowel Prep Kit?
The active ingredient in Suprep Bowel Prep Kit is sodium sulfate, potassium sulfate and magnesium sulfate, 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.