FDA Orange Book
Generic for Mozobil
Mozobil contains plerixafor. 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 Mozobil is plerixafor. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Mozobil products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | 24MG/1.2ML (20MG/ML) | Marketed (Rx) | AP | 7 | AP |
NDA 022311, held by GENZYME CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic plerixafor
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL EU LTD | 215334 | AP (A-rated, therapeutically equivalent) | July 24, 2023 | 24MG/1.2ML (20MG/ML) |
| DR REDDYS LABORATORIES LTD | 205182 | AP (A-rated, therapeutically equivalent) | July 24, 2023 | 24MG/1.2ML (20MG/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 213672 | AP (A-rated, therapeutically equivalent) | July 24, 2023 | 24MG/1.2ML (20MG/ML) |
| MEITHEAL PHARMACEUTICALS INC | 215698 | AP (A-rated, therapeutically equivalent) | July 24, 2023 | 24MG/1.2ML (20MG/ML) |
| MSN LABORATORIES PRIVATE LTD | 211901 | AP (A-rated, therapeutically equivalent) | July 24, 2023 | 24MG/1.2ML (20MG/ML) |
| GLAND PHARMA LTD | 206644 | AP (A-rated, therapeutically equivalent) | May 3, 2024 | 24MG/1.2ML (20MG/ML) |
| HETERO LABS LTD UNIT VI | 217560 | AP (A-rated, therapeutically equivalent) | June 16, 2025 | 24MG/1.2ML (20MG/ML) |
Mozobil NDC codes
Questions
Is there a generic for Mozobil?
Yes. The generic name for Mozobil is plerixafor. 7 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 Mozobil?
The active ingredient in Mozobil is plerixafor, 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.