FDA Orange Book
Generic for Ativan
Ativan contains lorazepam. 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 Ativan is lorazepam. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Ativan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 2MG/ML | Marketed (Rx) | AP | 4 | AP |
| injectable, injection | 4MG/ML | Marketed (Rx) | AP | 1 | AP |
| tablet, oral | 0.5MG | Marketed (Rx) | AB | 8 | AB |
| tablet, oral | 1MG | Marketed (Rx) | AB | 8 | AB |
| tablet, oral | 2MG | Marketed (Rx) | AB | 8 | AB |
NDA 018140, 017794, held by HIKMA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lorazepam
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 071141 | AB (A-rated, therapeutically equivalent) | April 21, 1987 | 0.5MG, 1MG, 2MG |
| WATSON LABORATORIES INC | 072926 | AB (A-rated, therapeutically equivalent) | October 31, 1991 | 0.5MG |
| WATSON LABORATORIES INC | 072927 | AB (A-rated, therapeutically equivalent) | October 31, 1991 | 1MG |
| WATSON LABORATORIES INC | 072928 | AB (A-rated, therapeutically equivalent) | October 31, 1991 | 2MG |
| HOSPIRA INC | 074243 | AP (A-rated, therapeutically equivalent) | April 12, 1994 | 2MG/ML, 4MG/ML |
| RISING PHARMA HOLDINGS INC | 075025 | AP (A-rated, therapeutically equivalent) | July 23, 1998 | 2MG/ML |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 076045 | AB (A-rated, therapeutically equivalent) | August 29, 2001 | 0.5MG, 1MG, 2MG |
| INTERNATIONAL MEDICATION SYSTEMS LTD | 076150 | AP (A-rated, therapeutically equivalent) | November 15, 2004 | 2MG/ML |
| OXFORD PHARMACEUTICALS LLC | 077754 | AB (A-rated, therapeutically equivalent) | May 10, 2006 | 0.5MG, 1MG, 2MG |
| ANI PHARMACEUTICALS INC | 077396 | AB (A-rated, therapeutically equivalent) | December 13, 2006 | 0.5MG, 1MG, 2MG |
| LEADING PHARMA LLC | 078203 | AB (A-rated, therapeutically equivalent) | July 30, 2007 | 0.5MG, 1MG, 2MG |
| AUROBINDO PHARMA LTD | 203572 | AB (A-rated, therapeutically equivalent) | December 22, 2017 | 0.5MG, 1MG, 2MG |
| FRESENIUS KABI USA LLC | 217598 | AP (A-rated, therapeutically equivalent) | November 18, 2024 | 2MG/ML |
| GRAVITI PHARMACEUTICALS PRIVATE LTD | 218597 | AB (A-rated, therapeutically equivalent) | July 24, 2025 | 0.5MG, 1MG, 2MG |
Ativan NDC codes
Questions
Is there a generic for Ativan?
Yes. The generic name for Ativan is lorazepam. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Ativan?
The active ingredient in Ativan is lorazepam, 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.
More on Ativan and Lorazepam
- What is Ativan used for?FDA label uses
- Is Ativan a controlled substance?Schedule IV
- What is Lorazepam used for?FDA label uses
- Is Lorazepam a controlled substance?Schedule IV
- Generic for Loreev XRFDA Orange Book
- Benzodiazepines listFDA drug class
- NDC 0187-0063Ativan NDC record
- NDC 0187-0064Ativan NDC record
- NDC 0187-0065Ativan NDC record
- Schedule IV drugs listDEA schedule