FDA Orange Book
Generic for Marcaine Hydrochloride
Marcaine Hydrochloride contains bupivacaine. 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 Marcaine Hydrochloride is bupivacaine. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Marcaine Hydrochloride products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 0.25% | Marketed (Rx) | AP | 12 | AP |
| injectable, injection | 0.5% | Marketed (Rx) | AP | 13 | AP |
NDA 016964, held by HOSPIRA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic bupivacaine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HOSPIRA INC | 070584 | AP (A-rated, therapeutically equivalent) | February 17, 1986 | 0.5% |
| FRESENIUS KABI USA LLC | 070552 | AP (A-rated, therapeutically equivalent) | May 21, 1986 | 0.25% |
| FRESENIUS KABI USA LLC | 070553 | AP (A-rated, therapeutically equivalent) | May 21, 1986 | 0.5% |
| HOSPIRA INC | 070583 | AP (A-rated, therapeutically equivalent) | February 17, 1987 | 0.25% |
| HOSPIRA INC | 070590 | AP (A-rated, therapeutically equivalent) | February 17, 1987 | 0.25% |
| HOSPIRA INC | 070597 | AP (A-rated, therapeutically equivalent) | March 3, 1987 | 0.5% |
| HOSPIRA INC | 070609 | AP (A-rated, therapeutically equivalent) | March 3, 1987 | 0.5% |
| ONESOURCE SPECIALTY PTE LTD | 091503 | AP (A-rated, therapeutically equivalent) | October 18, 2011 | 0.25%, 0.5% |
| ONESOURCE SPECIALTY PTE LTD | 091487 | AP (A-rated, therapeutically equivalent) | October 18, 2011 | 0.25%, 0.5% |
| EUGIA PHARMA SPECIALITIES LTD | 203895 | AP (A-rated, therapeutically equivalent) | November 5, 2013 | 0.25%, 0.5% |
| EUGIA PHARMA SPECIALITIES LTD | 207183 | AP (A-rated, therapeutically equivalent) | May 13, 2016 | 0.25%, 0.5% |
| HIKMA PHARMACEUTICALS | 204842 | AP (A-rated, therapeutically equivalent) | February 11, 2021 | 0.25%, 0.5% |
| HIKMA PHARMACEUTICALS | 205141 | AP (A-rated, therapeutically equivalent) | February 11, 2021 | 0.25%, 0.5% |
| SOMERSET THERAPEUTICS LLC | 217792 | AP (A-rated, therapeutically equivalent) | November 20, 2023 | 0.25%, 0.5% |
| ASPIRO PHARMA LTD | 217821 | AP (A-rated, therapeutically equivalent) | March 27, 2024 | 0.25%, 0.5% |
| ADAPTIS PHARMA PRIVATE LTD | 220493 | AP (A-rated, therapeutically equivalent) | April 22, 2026 | 0.25%, 0.5% |
Marcaine Hydrochloride NDC codes
Questions
Is there a generic for Marcaine Hydrochloride?
Yes. The generic name for Marcaine Hydrochloride is bupivacaine. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Marcaine Hydrochloride?
The active ingredient in Marcaine Hydrochloride is bupivacaine, 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.