FDA Orange Book
Generic for Amoxil
Amoxil contains amoxicillin. 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 Amoxil is amoxicillin. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 11 of the 13 Amoxil products the Orange Book lists.
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Amoxil products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 250MG | Discontinued | None | 7 | AB |
| capsule, oral | 500MG | Discontinued | None | 7 | AB |
| for suspension, oral | 125MG/5ML | Discontinued | None | 5 | AB |
| for suspension, oral | 200MG/5ML | Discontinued | None | 4 | AB |
| for suspension, oral | 250MG/5ML | Discontinued | None | 6 | AB |
| for suspension, oral | 400MG/5ML | Marketed (Rx) | AB | 5 | AB |
| for suspension, oral | 50MG/ML | Discontinued | None | 2 | AB |
| tablet, chewable, oral | 125MG | Discontinued | None | 1 | None |
| tablet, chewable, oral | 200MG | Discontinued | None | 0 | None |
| tablet, chewable, oral | 250MG | Discontinued | None | 1 | None |
| tablet, chewable, oral | 400MG | Discontinued | None | 0 | None |
| tablet, oral | 500MG | Discontinued | None | 3 | AB |
| tablet, oral | 875MG | Discontinued | None | 4 | AB |
NDA 050459, 050460, 050760, 050542, 050761, 050754, 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 amoxicillin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 064076 | AB (A-rated, therapeutically equivalent) | September 30, 1994 | 250MG, 500MG |
| CHARTWELL RX SCIENCES LLC | 064013 | None (No TE code listed) | September 11, 1995 | 125MG, 250MG |
| CHARTWELL RX SCIENCES LLC | 065056 | AB (A-rated, therapeutically equivalent) | September 18, 2000 | 500MG, 875MG |
| CHARTWELL RX SCIENCES LLC | 065119 | AB (A-rated, therapeutically equivalent) | December 4, 2002 | 200MG/5ML, 400MG/5ML |
| SANDOZ INC | 065228 | AB (A-rated, therapeutically equivalent) | July 13, 2005 | 500MG, 875MG |
| AUROBINDO PHARMA LTD | 065271 | AB (A-rated, therapeutically equivalent) | November 9, 2005 | 250MG, 500MG |
| AUROBINDO PHARMA LTD | 065256 | AB (A-rated, therapeutically equivalent) | November 9, 2005 | 500MG, 875MG |
| HIKMA PHARMACEUTICALS | 065255 | AB (A-rated, therapeutically equivalent) | March 29, 2006 | 875MG |
| HIKMA PHARMACEUTICALS | 065322 | AB (A-rated, therapeutically equivalent) | June 19, 2006 | 125MG/5ML, 250MG/5ML |
| HIKMA PHARMACEUTICALS | 065325 | AB (A-rated, therapeutically equivalent) | June 19, 2006 | 200MG/5ML, 400MG/5ML |
| AUROBINDO PHARMA LTD | 065334 | AB (A-rated, therapeutically equivalent) | December 28, 2006 | 200MG/5ML, 400MG/5ML |
| HIKMA PHARMACEUTICALS | 065291 | AB (A-rated, therapeutically equivalent) | February 5, 2007 | 250MG, 500MG |
| SANDOZ INC | 065387 | AB (A-rated, therapeutically equivalent) | March 26, 2007 | 125MG/5ML, 250MG/5ML |
| SANDOZ INC | 065378 | AB (A-rated, therapeutically equivalent) | March 26, 2007 | 200MG/5ML, 400MG/5ML |
| CHARTWELL RX SCIENCES LLC | 065319 | AB (A-rated, therapeutically equivalent) | June 18, 2007 | 400MG/5ML |
| AUROBINDO PHARMA LTD | 204030 | AB (A-rated, therapeutically equivalent) | September 15, 2014 | 125MG/5ML, 250MG/5ML |
| MICRO LABS LTD | 207471 | AB (A-rated, therapeutically equivalent) | June 24, 2022 | 250MG, 500MG |
| CHARTWELL LIFE MOLECULES LLC | 062058 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 250MG, 500MG |
| CHARTWELL RX SCIENCES LLC | 061926 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 250MG, 500MG |
| US ANTIBIOTICS LLC | 062216 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 250MG, 500MG |
| US ANTIBIOTICS LLC | 062226 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 125MG/5ML, 125MG/5ML, 250MG/5ML, 250MG/5ML, 50MG/ML |
| CHARTWELL RX SCIENCES LLC | 061931 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 250MG/5ML, 50MG/ML |
Amoxil NDC codes
Questions
Is there a generic for Amoxil?
Yes. The generic name for Amoxil is amoxicillin. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 11 of the 13 Amoxil products the Orange Book lists.
What is the generic name for Amoxil?
The active ingredient in Amoxil is amoxicillin, 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.