FDA Orange Book

Generic for Namzaric

Namzaric contains memantine and donepezil. 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 Namzaric is memantine and donepezil. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Namzaric products in the Orange Book

Namzaric products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, extended release, oral10MG;14MGMarketed (Rx)AB3AB
capsule, extended release, oral10MG;21MGMarketed (Rx)AB2AB
capsule, extended release, oral10MG;28MGMarketed (Rx)AB3AB
capsule, extended release, oral10MG;7MGMarketed (Rx)AB1AB

NDA 206439, 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 memantine and donepezil

Approved generic versions of Namzaric
CompanyANDATE codeApprovedStrengths
AMNEAL PHARMACEUTICALS LLC208328AB (A-rated, therapeutically equivalent)January 27, 201710MG;14MG, 10MG;21MG, 10MG;28MG, 10MG;7MG
ANI PHARMACEUTICALS INC208237AB (A-rated, therapeutically equivalent)December 15, 202310MG;21MG
MACLEODS PHARMACEUTICALS LTD208672AB (A-rated, therapeutically equivalent)July 15, 202510MG;14MG, 10MG;28MG
XIAMEN LP PHARMACUETICAL CO LTD216901AB (A-rated, therapeutically equivalent)July 15, 202510MG;14MG, 10MG;28MG

Namzaric patents

Patents listed for Namzaric
PatentExpiresCoversUse codeNDA
8039009March 24, 2029Method of useU-1641206439
8039009*PEDSeptember 24, 2029Method of useNone206439
8058291December 5, 2029Method of useU-1641206439

Namzaric NDC codes

Questions

Is there a generic for Namzaric?

Yes. The generic name for Namzaric is memantine and donepezil. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Namzaric?

The active ingredient in Namzaric is memantine and donepezil, per the FDA Orange Book.

When does the Namzaric patent expire?

The last patent listed for Namzaric in the Orange Book expires December 5, 2029. A listed patent expiry date is not a generic launch date.

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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