FDA Orange Book
Generic for TobraDex
TobraDex contains tobramycin 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 TobraDex is tobramycin and dexamethasone. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 TobraDex products the Orange Book lists.
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TobraDex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| ointment, ophthalmic | 0.1%;0.3% | Marketed (Rx) | None | 0 | None |
| suspension/drops, ophthalmic | 0.1%;0.3% | Marketed (Rx) | AB | 2 | AB |
NDA 050616, 050592, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tobramycin and dexamethasone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BAUSCH AND LOMB INC | 064134 | AB (A-rated, therapeutically equivalent) | October 27, 1999 | 0.1%;0.3% |
| PADAGIS US LLC | 212715 | AB (A-rated, therapeutically equivalent) | February 11, 2022 | 0.1%;0.3% |
TobraDex NDC codes
Questions
Is there a generic for TobraDex?
Yes. The generic name for TobraDex is tobramycin and dexamethasone. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 TobraDex products the Orange Book lists.
What is the generic name for TobraDex?
The active ingredient in TobraDex is tobramycin 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.
More on TobraDex and Tobramycin and Dexamethasone
- What is TobraDex used for?FDA label uses
- Is TobraDex a controlled substance?Federal schedule
- What is Tobramycin and Dexamethasone used for?FDA label uses
- Is Tobramycin and Dexamethasone a controlled substance?Federal schedule
- Generic for Tobradex STFDA Orange Book
- Aminoglycoside Antibacterials listFDA drug class
- Corticosteroids listFDA drug class
- NDC 0078-0876TobraDex NDC record