FDA Orange Book
Generic for Cortisporin
Cortisporin contains neomycin, polymyxin b, bacitracin zinc and hydrocortisone. 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 Cortisporin is neomycin, polymyxin b, bacitracin zinc and hydrocortisone. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT. Generics match 3 of the 5 Cortisporin products the Orange Book lists.
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Cortisporin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | Discontinued | None | 0 | None |
| ointment, ophthalmic | 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | Discontinued | None | 1 | None |
| ointment, topical | 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM | Discontinued | None | 0 | None |
| solution/drops, otic | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | Discontinued | None | 4 | AT |
| suspension/drops, ophthalmic | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | Discontinued | None | 1 | None |
NDA 050218, 050416, 050168, 050479, 050169, held by MONARCH PHARMACEUTICALS LLC. 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, bacitracin zinc and hydrocortisone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 062423 | AT (A-rated, therapeutically equivalent) | August 25, 1983 | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML |
| SANDOZ INC | 062874 | None (No TE code listed) | May 11, 1988 | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML |
| BAUSCH AND LOMB INC | 064068 | None (No TE code listed) | October 30, 1995 | 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM |
| BAUSCH AND LOMB INC | 064053 | AT (A-rated, therapeutically equivalent) | December 29, 1995 | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML |
| AMNEAL EU LTD | 217803 | AT (A-rated, therapeutically equivalent) | October 29, 2025 | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML |
| ORBICULAR PHARMACEUTICAL TECHNOLOGIES PVT LTD | 220938 | AT (A-rated, therapeutically equivalent) | August 27, 2026 | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML |
Questions
Is there a generic for Cortisporin?
Yes. The generic name for Cortisporin is neomycin, polymyxin b, bacitracin zinc and hydrocortisone. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT. Generics match 3 of the 5 Cortisporin products the Orange Book lists.
What is the generic name for Cortisporin?
The active ingredient in Cortisporin is neomycin, polymyxin b, bacitracin zinc and hydrocortisone, 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.