FDA Orange Book
Generic for Maxitrol
Maxitrol contains neomycin, polymyxin b and dexamethasone. 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 Maxitrol is neomycin, polymyxin b and dexamethasone. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
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Maxitrol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| ointment, ophthalmic | 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | Marketed (Rx) | AT | 1 | AT |
| suspension/drops, ophthalmic | 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | Marketed (Rx) | AT | 2 | AT |
NDA 050065, 050023, 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 neomycin, polymyxin b and dexamethasone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 062341 | AT (A-rated, therapeutically equivalent) | May 22, 1984 | 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML |
| BAUSCH AND LOMB INC | 064063 | AT (A-rated, therapeutically equivalent) | July 25, 1994 | 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM |
| BAUSCH AND LOMB INC | 064135 | AT (A-rated, therapeutically equivalent) | September 13, 1995 | 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML |
Maxitrol NDC codes
Questions
Is there a generic for Maxitrol?
Yes. The generic name for Maxitrol is neomycin, polymyxin b and dexamethasone. 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 Maxitrol?
The active ingredient in Maxitrol is neomycin, polymyxin b and dexamethasone, 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.