FDA Orange Book
Generic for Miacalcin
Miacalcin contains calcitonin salmon. 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 Miacalcin is calcitonin salmon. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 2 of the 3 Miacalcin products the Orange Book lists.
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Miacalcin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 100 IU/ML | Discontinued | None | 0 | None |
| injectable, injection | 200 IU/ML | Marketed (Rx) | AP | 8 | AP |
| spray, metered, nasal | 200 IU/SPRAY | Discontinued | None | 2 | AB |
NDA 017808, 020313, held by MYLAN IRELAND LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic calcitonin salmon
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 076396 | AB (A-rated, therapeutically equivalent) | November 17, 2008 | 200 IU/SPRAY |
| PH HEALTH LTD | 076979 | AB (A-rated, therapeutically equivalent) | June 8, 2009 | 200 IU/SPRAY |
| CUSTOPHARM INC | 212416 | AP (A-rated, therapeutically equivalent) | May 14, 2021 | 200 IU/ML |
| PH HEALTH LTD | 209358 | AP (A-rated, therapeutically equivalent) | November 10, 2021 | 200 IU/ML |
| DR REDDYS LABORATORIES LTD | 215715 | AP (A-rated, therapeutically equivalent) | April 11, 2024 | 200 IU/ML |
| CIPLA LTD | 213766 | AP (A-rated, therapeutically equivalent) | September 20, 2024 | 200 IU/ML |
| FRESENIUS KABI USA LLC | 212675 | AP (A-rated, therapeutically equivalent) | December 5, 2024 | 200 IU/ML |
| SAGENT PHARMACEUTICALS | 219196 | AP (A-rated, therapeutically equivalent) | July 9, 2025 | 200 IU/ML |
| AMNEAL EU LTD | 216294 | AP (A-rated, therapeutically equivalent) | September 26, 2025 | 200 IU/ML |
| ZYDUS PHARMACEUTICALS USA INC | 215864 | AP (A-rated, therapeutically equivalent) | March 4, 2026 | 200 IU/ML |
Miacalcin NDC codes
Questions
Is there a generic for Miacalcin?
Yes. The generic name for Miacalcin is calcitonin salmon. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 2 of the 3 Miacalcin products the Orange Book lists.
What is the generic name for Miacalcin?
The active ingredient in Miacalcin is calcitonin salmon, 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.