FDA Orange Book
Generic for Nimbex
Nimbex contains cisatracurium. 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 Nimbex is cisatracurium. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Nimbex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 2MG BASE/ML | Discontinued | None | 20 | AP |
NDA 020551, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cisatracurium
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 200159 | AP (A-rated, therapeutically equivalent) | February 3, 2012 | EQ 2MG BASE/ML |
| SANDOZ INC | 200154 | AP (A-rated, therapeutically equivalent) | February 3, 2012 | EQ 2MG BASE/ML |
| FRESENIUS KABI USA LLC | 203183 | AP (A-rated, therapeutically equivalent) | February 26, 2015 | EQ 2MG BASE/ML |
| FRESENIUS KABI USA LLC | 203182 | AP (A-rated, therapeutically equivalent) | February 26, 2015 | EQ 2MG BASE/ML |
| HOSPIRA INC | 203236 | AP (A-rated, therapeutically equivalent) | March 30, 2018 | EQ 2MG BASE/ML |
| HOSPIRA INC | 203238 | AP (A-rated, therapeutically equivalent) | March 30, 2018 | EQ 2MG BASE/ML |
| SOMERSET THERAPEUTICS LLC | 206791 | AP (A-rated, therapeutically equivalent) | February 20, 2019 | EQ 2MG BASE/ML |
| SOMERSET THERAPEUTICS LLC | 209132 | AP (A-rated, therapeutically equivalent) | April 24, 2019 | EQ 2MG BASE/ML |
| MEITHEAL PHARMACEUTICALS INC | 211668 | AP (A-rated, therapeutically equivalent) | April 25, 2019 | EQ 2MG BASE/ML |
| MEITHEAL PHARMACEUTICALS INC | 211669 | AP (A-rated, therapeutically equivalent) | April 25, 2019 | EQ 2MG BASE/ML |
| ZYDUS PHARMACEUTICALS USA INC | 212171 | AP (A-rated, therapeutically equivalent) | November 4, 2019 | EQ 2MG BASE/ML |
| SAGENT PHARMACEUTICALS INC | 201836 | AP (A-rated, therapeutically equivalent) | November 6, 2020 | EQ 2MG BASE/ML |
| SAGENT PHARMACEUTICALS INC | 201851 | AP (A-rated, therapeutically equivalent) | November 6, 2020 | EQ 2MG BASE/ML |
| PIRAMAL HEALTHCARE UK LTD | 212432 | AP (A-rated, therapeutically equivalent) | March 11, 2022 | EQ 2MG BASE/ML |
| GLAND PHARMA LTD | 215516 | AP (A-rated, therapeutically equivalent) | May 24, 2022 | EQ 2MG BASE/ML, EQ 2MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 203078 | AP (A-rated, therapeutically equivalent) | June 28, 2022 | EQ 2MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 203079 | AP (A-rated, therapeutically equivalent) | April 19, 2023 | EQ 2MG BASE/ML |
| CAPLIN STERILES LTD | 217725 | AP (A-rated, therapeutically equivalent) | June 9, 2023 | EQ 2MG BASE/ML |
| HAINAN POLY PHARM CO LTD | 216539 | AP (A-rated, therapeutically equivalent) | August 27, 2024 | EQ 2MG BASE/ML |
Questions
Is there a generic for Nimbex?
Yes. The generic name for Nimbex is cisatracurium. 12 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 Nimbex?
The active ingredient in Nimbex is cisatracurium, 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.