FDA Orange Book

Generic for Aciphex

Aciphex contains rabeprazole. 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 Aciphex is rabeprazole. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Aciphex products the Orange Book lists.

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Aciphex products in the Orange Book

Aciphex products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, delayed release, oral10MGDiscontinuedNone0None
tablet, delayed release, oral20MGMarketed (Rx)AB8AB

NDA 020973, held by WAYLIS THERAPEUTICS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic rabeprazole

Approved generic versions of Aciphex
CompanyANDATE codeApprovedStrengths
CHARTWELL RX SCIENCES LLC078964AB (A-rated, therapeutically equivalent)November 8, 201320MG
DR REDDYS LABORATORIES LTD076824AB (A-rated, therapeutically equivalent)November 8, 201320MG
LANNETT CO INC090678AB (A-rated, therapeutically equivalent)November 8, 201320MG
TORRENT PHARMACEUTICALS LTD202376AB (A-rated, therapeutically equivalent)November 8, 201320MG
AMNEAL PHARMACEUTICALS204179AB (A-rated, therapeutically equivalent)July 31, 201520MG
RUBICON RESEARCH LTD204237AB (A-rated, therapeutically equivalent)November 18, 201520MG
QUAGEN PHARMACEUTICALS LLC205761AB (A-rated, therapeutically equivalent)February 17, 201720MG
ALKEM LABORATORIES LTD208644AB (A-rated, therapeutically equivalent)April 24, 201820MG

Aciphex NDC codes

Questions

Is there a generic for Aciphex?

Yes. The generic name for Aciphex is rabeprazole. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Aciphex products the Orange Book lists.

What is the generic name for Aciphex?

The active ingredient in Aciphex is rabeprazole, 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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