FDA Orange Book
Generic for Nimbex Preservative Free
Nimbex Preservative Free 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 Preservative Free 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 Preservative Free products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 10MG BASE/ML | Discontinued | None | 12 | AP |
| 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 | 200154 | AP (A-rated, therapeutically equivalent) | February 3, 2012 | EQ 10MG BASE/ML, EQ 2MG BASE/ML |
| SANDOZ INC | 200159 | AP (A-rated, therapeutically equivalent) | February 3, 2012 | EQ 2MG BASE/ML |
| FRESENIUS KABI USA LLC | 203182 | AP (A-rated, therapeutically equivalent) | February 26, 2015 | EQ 10MG BASE/ML, EQ 2MG BASE/ML |
| FRESENIUS KABI USA LLC | 203183 | AP (A-rated, therapeutically equivalent) | February 26, 2015 | EQ 2MG BASE/ML |
| HOSPIRA INC | 203236 | AP (A-rated, therapeutically equivalent) | March 30, 2018 | EQ 10MG BASE/ML, 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 10MG BASE/ML, 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 10MG BASE/ML, 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 10MG BASE/ML, EQ 2MG BASE/ML |
| SAGENT PHARMACEUTICALS INC | 201836 | AP (A-rated, therapeutically equivalent) | November 6, 2020 | EQ 10MG BASE/ML, 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 10MG BASE/ML, EQ 2MG BASE/ML |
| GLAND PHARMA LTD | 215516 | AP (A-rated, therapeutically equivalent) | May 24, 2022 | EQ 10MG BASE/ML, EQ 2MG BASE/ML, 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 10MG BASE/ML, EQ 2MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 203078 | AP (A-rated, therapeutically equivalent) | December 18, 2023 | EQ 10MG BASE/ML, EQ 2MG BASE/ML |
| HAINAN POLY PHARM CO LTD | 216539 | AP (A-rated, therapeutically equivalent) | August 27, 2024 | EQ 10MG BASE/ML, EQ 2MG BASE/ML |
Questions
Is there a generic for Nimbex Preservative Free?
Yes. The generic name for Nimbex Preservative Free 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 Preservative Free?
The active ingredient in Nimbex Preservative Free 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.