FDA Orange Book
Generic for Versed
Versed contains midazolam. 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 Versed is midazolam. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AP.
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Versed products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 1MG BASE/ML | Discontinued | None | 14 | AP |
| injectable, injection | EQ 5MG BASE/ML | Discontinued | None | 14 | AP |
| syrup, oral | EQ 2MG BASE/ML | Discontinued | None | 2 | AA |
NDA 018654, 020942, held by HLR TECHNOLOGY. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic midazolam
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 075154 | AP (A-rated, therapeutically equivalent) | June 20, 2000 | EQ 1MG BASE/ML, EQ 5MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 075243 | AP (A-rated, therapeutically equivalent) | June 20, 2000 | EQ 1MG BASE/ML, EQ 5MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 075324 | AP (A-rated, therapeutically equivalent) | June 20, 2000 | EQ 1MG BASE/ML, EQ 5MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 075421 | AP (A-rated, therapeutically equivalent) | June 20, 2000 | EQ 1MG BASE/ML, EQ 5MG BASE/ML |
| HOSPIRA INC | 075293 | AP (A-rated, therapeutically equivalent) | June 20, 2000 | EQ 1MG BASE/ML, EQ 5MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 075247 | AP (A-rated, therapeutically equivalent) | June 23, 2000 | EQ 1MG BASE/ML, EQ 5MG BASE/ML |
| RISING PHARMA HOLDINGS INC | 075494 | AP (A-rated, therapeutically equivalent) | June 30, 2000 | EQ 1MG BASE/ML, EQ 5MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 075873 | AA (A-rated, therapeutically equivalent) | April 30, 2002 | EQ 2MG BASE/ML |
| HOSPIRA INC | 075857 | AP (A-rated, therapeutically equivalent) | July 22, 2002 | EQ 1MG BASE/ML, EQ 5MG BASE/ML |
| PADAGIS US LLC | 076379 | AA (A-rated, therapeutically equivalent) | May 2, 2005 | EQ 2MG BASE/ML |
| ONESOURCE SPECIALTY PTE LTD | 090315 | AP (A-rated, therapeutically equivalent) | November 29, 2010 | EQ 1MG BASE/ML, EQ 5MG BASE/ML |
| ONESOURCE SPECIALTY PTE LTD | 090316 | AP (A-rated, therapeutically equivalent) | May 4, 2011 | EQ 1MG BASE/ML, EQ 5MG BASE/ML |
| GLAND PHARMA LTD | 090850 | AP (A-rated, therapeutically equivalent) | January 25, 2012 | EQ 5MG BASE/ML |
| GLAND PHARMA LTD | 090696 | AP (A-rated, therapeutically equivalent) | February 29, 2012 | EQ 1MG BASE/ML |
| FRESENIUS KABI USA LLC | 203460 | AP (A-rated, therapeutically equivalent) | August 22, 2014 | EQ 1MG BASE/ML, EQ 5MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 212847 | AP (A-rated, therapeutically equivalent) | December 11, 2020 | EQ 1MG BASE/ML, EQ 5MG BASE/ML |
| MICRO LABS LTD | 217504 | AP (A-rated, therapeutically equivalent) | August 21, 2023 | EQ 1MG BASE/ML, EQ 5MG BASE/ML |
Questions
Is there a generic for Versed?
Yes. The generic name for Versed is midazolam. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AP.
What is the generic name for Versed?
The active ingredient in Versed is midazolam, 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.