FDA Orange Book
Generic for Prepopik
Prepopik contains citric acid, magnesium oxide and sodium picosulfate. 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 Prepopik is citric acid, magnesium oxide and sodium picosulfate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
Run it in Rivvi
Map Prepopik and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Prepopik products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, oral | 12GM/PACKET;3.5GM/PACKET;10MG/PACKET | Discontinued | None | 1 | None |
NDA 202535, held by FERRING PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic citric acid, magnesium oxide and sodium picosulfate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HETERO LABS LTD UNIT V | 212789 | None (No TE code listed) | July 18, 2022 | 12GM/PACKET;3.5GM/PACKET;10MG/PACKET |
Prepopik patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8450338 | October 10, 2028 | Drug product | None | 202535 |
| 8481083 | October 10, 2028 | Drug product | None | 202535 |
Questions
Is there a generic for Prepopik?
Yes. The generic name for Prepopik is citric acid, magnesium oxide and sodium picosulfate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Prepopik?
The active ingredient in Prepopik is citric acid, magnesium oxide and sodium picosulfate, per the FDA Orange Book.
When does the Prepopik patent expire?
The last patent listed for Prepopik in the Orange Book expires October 10, 2028. A listed patent expiry date is not a generic launch date.
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.