FDA Orange Book

Generic for Nalfon

Nalfon contains fenoprofen. 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 Nalfon is fenoprofen. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Nalfon products the Orange Book lists.

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Nalfon products in the Orange Book

Nalfon products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oralEQ 200MG BASEDiscontinuedNone2AB
capsule, oralEQ 300MG BASEDiscontinuedNone2AB
capsule, oralEQ 400MG BASEDiscontinuedNone1None
tablet, oralEQ 600MG BASEDiscontinuedNone0None

NDA 017604, 017710, held by PHARMACO LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic fenoprofen

Approved generic versions of Nalfon
CompanyANDATE codeApprovedStrengths
MISEMER PHARMACEUTICALS INC215548AB (A-rated, therapeutically equivalent)May 16, 2023EQ 200MG BASE, EQ 300MG BASE
RISING PHARMA HOLDINGS INC214475AB (A-rated, therapeutically equivalent)July 26, 2024EQ 200MG BASE, EQ 300MG BASE, EQ 400MG BASE

Questions

Is there a generic for Nalfon?

Yes. The generic name for Nalfon is fenoprofen. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 4 Nalfon products the Orange Book lists.

What is the generic name for Nalfon?

The active ingredient in Nalfon is fenoprofen, 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.

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