FDA Orange Book
Generic for Zithromax
Zithromax contains azithromycin. 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 Zithromax is azithromycin. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 6 of the 8 Zithromax products the Orange Book lists.
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Zithromax 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 suspension, oral | EQ 100MG BASE/5ML | Marketed (Rx) | AB | 6 | AB |
| for suspension, oral | EQ 1GM BASE/PACKET | Discontinued | None | 0 | None |
| for suspension, oral | EQ 200MG BASE/5ML | Marketed (Rx) | AB | 6 | AB |
| injectable, injection | EQ 500MG BASE/VIAL | Discontinued | None | 5 | AP |
| tablet, oral | EQ 250MG BASE | Marketed (Rx) | AB | 9 | AB |
| tablet, oral | EQ 500MG BASE | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | EQ 600MG BASE | Discontinued | None | 9 | AB |
NDA 050670, 050710, 050693, 050733, 050711, 050784, 050730, held by PFIZER CHEMICALS DIV PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic azithromycin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PLIVA INC | 065225 | AB (A-rated, therapeutically equivalent) | November 14, 2005 | EQ 250MG BASE |
| SANDOZ INC | 065211 | AB (A-rated, therapeutically equivalent) | November 14, 2005 | EQ 250MG BASE |
| PLIVA INC | 065223 | AB (A-rated, therapeutically equivalent) | November 14, 2005 | EQ 500MG BASE |
| SANDOZ INC | 065212 | AB (A-rated, therapeutically equivalent) | November 14, 2005 | EQ 500MG BASE |
| TEVA PHARMACEUTICALS USA INC | 065193 | AB (A-rated, therapeutically equivalent) | November 14, 2005 | EQ 500MG BASE |
| PLIVA INC | 065218 | AB (A-rated, therapeutically equivalent) | November 14, 2005 | EQ 600MG BASE |
| SANDOZ INC | 065209 | AB (A-rated, therapeutically equivalent) | November 14, 2005 | EQ 600MG BASE |
| FRESENIUS KABI USA LLC | 065179 | AP (A-rated, therapeutically equivalent) | December 13, 2005 | EQ 500MG BASE/VIAL |
| PLIVA INC | 065246 | AB (A-rated, therapeutically equivalent) | July 5, 2006 | EQ 100MG BASE/5ML, EQ 200MG BASE/5ML |
| CHARTWELL RX SCIENCES LLC | 065404 | AB (A-rated, therapeutically equivalent) | February 11, 2008 | EQ 250MG BASE |
| CHARTWELL RX SCIENCES LLC | 065405 | AB (A-rated, therapeutically equivalent) | February 11, 2008 | EQ 500MG BASE |
| CHARTWELL RX SCIENCES LLC | 065302 | AB (A-rated, therapeutically equivalent) | February 11, 2008 | EQ 600MG BASE |
| HOSPIRA INC | 065500 | AP (A-rated, therapeutically equivalent) | June 26, 2009 | EQ 500MG BASE/VIAL |
| GLAND PHARMA LTD | 065501 | AP (A-rated, therapeutically equivalent) | November 9, 2009 | EQ 500MG BASE/VIAL |
| CHARTWELL RX SCIENCES LLC | 065488 | AB (A-rated, therapeutically equivalent) | May 15, 2015 | EQ 100MG BASE/5ML, EQ 200MG BASE/5ML |
| LUPIN LTD | 065398 | AB (A-rated, therapeutically equivalent) | May 15, 2015 | EQ 250MG BASE |
| LUPIN LTD | 065399 | AB (A-rated, therapeutically equivalent) | May 15, 2015 | EQ 500MG BASE |
| LUPIN LTD | 065400 | AB (A-rated, therapeutically equivalent) | May 15, 2015 | EQ 600MG BASE |
| EUGIA PHARMA SPECIALITIES LTD | 203294 | AP (A-rated, therapeutically equivalent) | June 19, 2015 | EQ 500MG BASE/VIAL |
| EPIC PHARMA LLC | 207531 | AB (A-rated, therapeutically equivalent) | April 9, 2018 | EQ 100MG BASE/5ML, EQ 200MG BASE/5ML |
| AUROBINDO PHARMA LTD | 207370 | AB (A-rated, therapeutically equivalent) | July 5, 2018 | EQ 250MG BASE |
| AUROBINDO PHARMA LTD | 207398 | AB (A-rated, therapeutically equivalent) | July 5, 2018 | EQ 500MG BASE |
| ZYDUS LIFESCIENCES GLOBAL FZE | 211147 | AB (A-rated, therapeutically equivalent) | July 31, 2018 | EQ 100MG BASE/5ML, EQ 200MG BASE/5ML |
| CSPC OUYI PHARMACEUTICAL CO LTD | 207566 | AB (A-rated, therapeutically equivalent) | September 24, 2018 | EQ 600MG BASE |
| AUROBINDO PHARMA LTD | 209201 | AB (A-rated, therapeutically equivalent) | October 9, 2018 | EQ 100MG BASE/5ML, EQ 200MG BASE/5ML |
| HAINAN POLY PHARM CO LTD | 203412 | AP (A-rated, therapeutically equivalent) | October 9, 2018 | EQ 500MG BASE/VIAL |
| CSPC OUYI PHARMACEUTICAL CO LTD | 208249 | AB (A-rated, therapeutically equivalent) | October 25, 2018 | EQ 500MG BASE |
| SUNSHINE LAKE PHARMA CO LTD | 209043 | AB (A-rated, therapeutically equivalent) | December 6, 2018 | EQ 600MG BASE |
| SUNSHINE LAKE PHARMA CO LTD | 209045 | AB (A-rated, therapeutically equivalent) | December 7, 2018 | EQ 250MG BASE |
| SUNSHINE LAKE PHARMA CO LTD | 209044 | AB (A-rated, therapeutically equivalent) | December 7, 2018 | EQ 500MG BASE |
| BIONPHARMA INC | 209999 | AB (A-rated, therapeutically equivalent) | December 26, 2018 | EQ 600MG BASE |
| BIONPHARMA INC | 210000 | AB (A-rated, therapeutically equivalent) | February 26, 2019 | EQ 250MG BASE |
| BIONPHARMA INC | 210001 | AB (A-rated, therapeutically equivalent) | February 26, 2019 | EQ 500MG BASE |
| CSPC OUYI PHARMACEUTICAL CO LTD | 208250 | AB (A-rated, therapeutically equivalent) | April 17, 2019 | EQ 250MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 211793 | AB (A-rated, therapeutically equivalent) | January 27, 2020 | EQ 600MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 211791 | AB (A-rated, therapeutically equivalent) | January 28, 2020 | EQ 250MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 211792 | AB (A-rated, therapeutically equivalent) | January 28, 2020 | EQ 500MG BASE |
| CARLSBAD TECHNOLOGY INC | 211068 | AB (A-rated, therapeutically equivalent) | May 8, 2020 | EQ 600MG BASE |
| ZHEJIANG POLY PHARM CO LTD | 217036 | AB (A-rated, therapeutically equivalent) | July 27, 2023 | EQ 100MG BASE/5ML, EQ 200MG BASE/5ML |
Zithromax NDC codes
Questions
Is there a generic for Zithromax?
Yes. The generic name for Zithromax is azithromycin. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 6 of the 8 Zithromax products the Orange Book lists.
What is the generic name for Zithromax?
The active ingredient in Zithromax is azithromycin, 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.