FDA Orange Book
Generic for Forteo
Forteo contains teriparatide. 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 Forteo is teriparatide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Forteo products the Orange Book lists.
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Forteo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | 0.56MG/2.24ML (0.25MG/ML) | Marketed (Rx) | AP | 3 | AP |
| solution, subcutaneous | 0.75MG/3ML (0.25MG/ML) | Discontinued | None | 0 | None |
NDA 021318, held by ELI LILLY AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic teriparatide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 211097 | AP (A-rated, therapeutically equivalent) | November 16, 2023 | 0.56MG/2.24ML (0.25MG/ML) |
| TEVA PHARMACEUTICALS USA INC | 208569 | AP (A-rated, therapeutically equivalent) | November 16, 2023 | 0.56MG/2.24ML (0.25MG/ML) |
| AMPHASTAR PHARMACEUTICALS INC | 213641 | AP (A-rated, therapeutically equivalent) | December 12, 2025 | 0.56MG/2.24ML (0.25MG/ML) |
Forteo NDC codes
Questions
Is there a generic for Forteo?
Yes. The generic name for Forteo is teriparatide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Forteo products the Orange Book lists.
What is the generic name for Forteo?
The active ingredient in Forteo is teriparatide, 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 Forteo and Teriparatide
- What is Forteo used for?FDA label uses
- Is Forteo a controlled substance?Federal schedule
- What is Teriparatide used for?FDA label uses
- Is Teriparatide a controlled substance?Federal schedule
- Generic for BonsityFDA Orange Book
- Parathyroid Hormone Analogs listFDA drug class
- Forteo Medicare Part D coverageBy plan and state
- NDC 0002-8400Forteo NDC record
- NDC 0002-9678Forteo NDC record