FDA Orange Book
Is there a generic for Noxafil Powdermix Kit?
Noxafil Powdermix Kit contains posaconazole. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Noxafil Powdermix Kit (posaconazole). The Orange Book shows its last listed exclusivity ends January 27, 2029.
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Noxafil Powdermix Kit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, delayed release, oral | 300MG | Marketed (Rx) | None | 0 | None |
NDA 214770, held by MERCK SHARP AND DOHME CORP A SUB OF MERCK AND CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Noxafil Powdermix Kit exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-984 | New indication | January 27, 2029 | 214770 |
Noxafil Powdermix Kit NDC codes
Questions
Is there a generic for Noxafil Powdermix Kit?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Noxafil Powdermix Kit (posaconazole). The Orange Book shows its last listed exclusivity ends January 27, 2029.
What is the generic name for Noxafil Powdermix Kit?
The active ingredient in Noxafil Powdermix Kit is posaconazole, 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.