FDA Orange Book
Generic for Betoptic
Betoptic contains betaxolol. 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 Betoptic is betaxolol. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
Run it in Rivvi
Map Betoptic 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.
Betoptic products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | EQ 0.5% BASE | Marketed (Rx) | AT | 2 | AT |
NDA 019270, held by SANDOZ INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic betaxolol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| EUROFARMA INC | 075630 | AT (A-rated, therapeutically equivalent) | April 12, 2001 | EQ 0.5% BASE |
| CHARTWELL RX SCIENCES LLC | 078694 | AT (A-rated, therapeutically equivalent) | November 16, 2009 | EQ 0.5% BASE |
Betoptic NDC codes
Questions
Is there a generic for Betoptic?
Yes. The generic name for Betoptic is betaxolol. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
What is the generic name for Betoptic?
The active ingredient in Betoptic is betaxolol, 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.