FDA Orange Book
Generic for Diprivan
Diprivan contains propofol. 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 Diprivan is propofol. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Diprivan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 10MG/ML | Marketed (Rx) | AB | 10 | AB |
| injectable, injection | 10MG/ML | Discontinued | None | 10 | AB |
NDA 019627, 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 propofol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SAGENT PHARMACEUTICALS INC | 075102 | AB (A-rated, therapeutically equivalent) | January 4, 1999 | 10MG/ML, 10MG/ML |
| HIKMA PHARMACEUTICALS USA INC | 074848 | AB (A-rated, therapeutically equivalent) | April 19, 2005 | 10MG/ML, 10MG/ML |
| HOSPIRA INC | 077908 | AB (A-rated, therapeutically equivalent) | March 17, 2006 | 10MG/ML, 10MG/ML |
| DR REDDYS LABORATORIES INC | 205067 | AB (A-rated, therapeutically equivalent) | November 15, 2018 | 10MG/ML, 10MG/ML |
| INNOPHARMA LICENSING LLC A SUB OF PFIZER INC | 205576 | AB (A-rated, therapeutically equivalent) | September 16, 2020 | 10MG/ML, 10MG/ML |
| AVET LIFESCIENCES LTD | 206408 | AB (A-rated, therapeutically equivalent) | October 12, 2021 | 10MG/ML, 10MG/ML |
| ASPIRO PHARMA LTD | 217013 | AB (A-rated, therapeutically equivalent) | June 20, 2024 | 10MG/ML, 10MG/ML |
| AMNEAL EU LTD | 217525 | AB (A-rated, therapeutically equivalent) | August 15, 2024 | 10MG/ML, 10MG/ML |
| EMERGE BIOSCIENCE PTE LTD | 217945 | AB (A-rated, therapeutically equivalent) | December 2, 2025 | 10MG/ML, 10MG/ML |
| ADAPTIS PHARMA PRIVATE LTD | 220857 | AB (A-rated, therapeutically equivalent) | July 14, 2026 | 10MG/ML, 10MG/ML |
Diprivan NDC codes
Questions
Is there a generic for Diprivan?
Yes. The generic name for Diprivan is propofol. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Diprivan?
The active ingredient in Diprivan is propofol, 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.