FDA Orange Book
Generic for Sensorcaine
Sensorcaine 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 Sensorcaine is bupivacaine. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 4 of the 5 Sensorcaine products the Orange Book lists.
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Sensorcaine 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 |
| injectable, injection | 0.5%;0.0091MG/ML | Marketed (Rx) | AP | 2 | AP |
| injectable, injection | 0.75% | Marketed (Rx) | AP | 7 | AP |
| injectable, injection | 0.75%;0.0091MG/ML | Marketed (Rx) | AP | 0 | None |
NDA 018304, held by FRESENIUS KABI USA LLC. 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% |
| FRESENIUS KABI USA LLC | 070554 | AP (A-rated, therapeutically equivalent) | May 21, 1986 | 0.75% |
| 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% |
| HOSPIRA INC | 070585 | AP (A-rated, therapeutically equivalent) | March 3, 1987 | 0.75% |
| FRESENIUS KABI USA LLC | 070968 | AP (A-rated, therapeutically equivalent) | October 13, 1987 | 0.5%;0.0091MG/ML |
| SEPTODONT INC | 077250 | None (No TE code listed) | September 27, 2006 | 0.5%;0.0091MG/ML |
| 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%, 0.75% |
| EUGIA PHARMA SPECIALITIES LTD | 203895 | AP (A-rated, therapeutically equivalent) | November 5, 2013 | 0.25%, 0.5%, 0.75% |
| 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%, 0.75% |
| 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%, 0.75% |
| ADAPTIS PHARMA PRIVATE LTD | 220493 | AP (A-rated, therapeutically equivalent) | April 22, 2026 | 0.25%, 0.5%, 0.75% |
Sensorcaine NDC codes
Questions
Is there a generic for Sensorcaine?
Yes. The generic name for Sensorcaine is bupivacaine. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 4 of the 5 Sensorcaine products the Orange Book lists.
What is the generic name for Sensorcaine?
The active ingredient in Sensorcaine 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.
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