FDA Orange Book
Generic for Bactroban
Bactroban contains mupirocin. 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 Bactroban is mupirocin. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Bactroban products the Orange Book lists.
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Bactroban products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | EQ 2% BASE | Discontinued | None | 6 | AB |
| ointment, nasal | EQ 2% BASE | Discontinued | None | 0 | None |
| ointment, topical | 2% | Discontinued | None | 6 | AB |
NDA 050746, 050703, 050591, held by GLAXOSMITHKLINE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic mupirocin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 065123 | AB (A-rated, therapeutically equivalent) | November 7, 2003 | 2% |
| TEVA PHARMACEUTICALS USA INC | 065085 | AB (A-rated, therapeutically equivalent) | November 7, 2003 | 2% |
| SUN PHARMA CANADA INC | 065170 | AB (A-rated, therapeutically equivalent) | September 23, 2005 | 2% |
| FOUGERA PHARMACEUTICALS INC | 065192 | AB (A-rated, therapeutically equivalent) | November 30, 2005 | 2% |
| GLENMARK PHARMACEUTICALS INC USA | 090480 | AB (A-rated, therapeutically equivalent) | June 8, 2011 | 2% |
| GLENMARK PHARMACEUTICALS INC USA | 201587 | AB (A-rated, therapeutically equivalent) | January 24, 2013 | EQ 2% BASE |
| SUN PHARMA CANADA INC | 207116 | AB (A-rated, therapeutically equivalent) | April 27, 2020 | EQ 2% BASE |
| ENCUBE ETHICALS PRIVATE LTD | 213076 | AB (A-rated, therapeutically equivalent) | August 31, 2021 | EQ 2% BASE |
| ALEMBIC PHARMACEUTICALS LTD | 213053 | AB (A-rated, therapeutically equivalent) | November 16, 2021 | EQ 2% BASE |
| AMNEAL PHARMACEUTICALS LLC | 214811 | AB (A-rated, therapeutically equivalent) | November 15, 2022 | EQ 2% BASE |
| ENCUBE ETHICALS PRIVATE LTD | 217943 | AB (A-rated, therapeutically equivalent) | May 13, 2025 | 2% |
| ZYDUS LIFESCIENCES LTD | 218361 | AB (A-rated, therapeutically equivalent) | September 29, 2026 | EQ 2% BASE |
Questions
Is there a generic for Bactroban?
Yes. The generic name for Bactroban is mupirocin. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Bactroban products the Orange Book lists.
What is the generic name for Bactroban?
The active ingredient in Bactroban is mupirocin, 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.