FDA Orange Book
Is there a generic for Tuxarin ER?
Tuxarin ER contains codeine and chlorpheniramine. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tuxarin ER (codeine and chlorpheniramine). The Orange Book shows its last listed patent expires January 3, 2032.
Run it in Rivvi
Map Tuxarin ER 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.
Tuxarin ER products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 8MG;54.3MG | Marketed (Rx) | None | 0 | None |
NDA 206323, held by MAINPOINTE PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tuxarin ER patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9066942 | January 3, 2032 | Method of use | U-1716 | 206323 |
| 9107921 | January 3, 2032 | Drug product | None | 206323 |
Tuxarin ER NDC codes
Questions
Is there a generic for Tuxarin ER?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tuxarin ER (codeine and chlorpheniramine). The Orange Book shows its last listed patent expires January 3, 2032.
What is the generic name for Tuxarin ER?
The active ingredient in Tuxarin ER is codeine and chlorpheniramine, per the FDA Orange Book.
When does the Tuxarin ER patent expire?
The last patent listed for Tuxarin ER in the Orange Book expires January 3, 2032. 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.