FDA Orange Book

Is there a generic for Fosamax Plus D?

Fosamax Plus D contains alendronate and cholecalciferol. 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 Fosamax Plus D (alendronate and cholecalciferol).

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Fosamax Plus D products in the Orange Book

Fosamax Plus D products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oralEQ 70MG BASE;2,800 IUMarketed (Rx)None0None
tablet, oralEQ 70MG BASE;5,600 IUMarketed (Rx)None0None

NDA 021762, held by ORGANON LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Fosamax Plus D NDC codes

Questions

Is there a generic for Fosamax Plus D?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Fosamax Plus D (alendronate and cholecalciferol).

What is the generic name for Fosamax Plus D?

The active ingredient in Fosamax Plus D is alendronate and cholecalciferol, 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.

More on Fosamax Plus D and Alendronate and Cholecalciferol

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