FDA Orange Book
Is there a generic for Soltamox?
Soltamox contains tamoxifen. 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 Soltamox (tamoxifen).
Run it in Rivvi
Map Soltamox 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.
Soltamox products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | EQ 20MG BASE/10ML | Marketed (Rx) | None | 0 | None |
NDA 021807, held by MAYNE PHARMA COMMERCIAL LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Soltamox NDC codes
Questions
Is there a generic for Soltamox?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Soltamox (tamoxifen).
What is the generic name for Soltamox?
The active ingredient in Soltamox is tamoxifen, 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.