FDA Orange Book
Generic for Unipen
Unipen contains nafcillin. 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 Unipen is nafcillin. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 8 Unipen products the Orange Book lists.
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Unipen products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 250MG BASE | Discontinued | None | 0 | None |
| for solution, oral | EQ 250MG BASE/5ML | Discontinued | None | 0 | None |
| injectable, injection | EQ 10GM BASE/VIAL | Discontinued | None | 4 | AP |
| injectable, injection | EQ 20GM BASE/VIAL | Discontinued | None | 0 | None |
| injectable, injection | EQ 2GM BASE/VIAL | Discontinued | None | 5 | AP |
| injectable, injection | EQ 4GM BASE/VIAL | Discontinued | None | 0 | None |
| injectable, injection | EQ 500MG BASE/VIAL | Discontinued | None | 0 | None |
| tablet, oral | EQ 500MG BASE | Discontinued | None | 0 | None |
NDA 050111, 050199, 050320, 050462, held by WYETH AYERST LABORATORIES. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic nafcillin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ISTITUTO BIOCHIMICO ITALIANO SPA | 090005 | AP (A-rated, therapeutically equivalent) | April 20, 2011 | EQ 10GM BASE/VIAL |
| ACS DOBFAR SPA | 090002 | AP (A-rated, therapeutically equivalent) | June 30, 2011 | EQ 2GM BASE/VIAL |
| ANTIBIOTICE SA | 090560 | AP (A-rated, therapeutically equivalent) | October 3, 2011 | EQ 2GM BASE/VIAL |
| SAGENT PHARMACEUTICALS INC | 090580 | AP (A-rated, therapeutically equivalent) | August 24, 2012 | EQ 10GM BASE/VIAL |
| SAGENT PHARMACEUTICALS INC | 090582 | AP (A-rated, therapeutically equivalent) | August 24, 2012 | EQ 2GM BASE/VIAL |
| EUGIA PHARMA SPECIALITIES LTD | 091614 | AP (A-rated, therapeutically equivalent) | December 26, 2012 | EQ 10GM BASE/VIAL |
| EUGIA PHARMA SPECIALITIES LTD | 091613 | AP (A-rated, therapeutically equivalent) | December 26, 2012 | EQ 2GM BASE/VIAL |
| ONESOURCE SPECIALTY PTE LTD | 200002 | AP (A-rated, therapeutically equivalent) | April 7, 2014 | EQ 2GM BASE/VIAL |
| STERISCIENCE PTE LTD | 203830 | AP (A-rated, therapeutically equivalent) | September 25, 2026 | EQ 10GM BASE/VIAL |
Questions
Is there a generic for Unipen?
Yes. The generic name for Unipen is nafcillin. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 8 Unipen products the Orange Book lists.
What is the generic name for Unipen?
The active ingredient in Unipen is nafcillin, 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.