FDA Orange Book
Generic for Pitocin
Pitocin contains oxytocin. 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 Pitocin is oxytocin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 3 Pitocin products the Orange Book lists.
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Pitocin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 100USP UNITS/10ML (10USP UNITS/ML) | Marketed (Rx) | AP | 1 | AP |
| injectable, injection | 10USP UNITS/ML (10USP UNITS/ML) | Marketed (Rx) | AP | 2 | AP |
| injectable, injection | 500USP UNITS/50ML (10USP UNITS/ML) | Marketed (Rx) | None | 0 | None |
NDA 018261, held by PH HEALTH LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic oxytocin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA FARMACEUTICA PORTUGAL SA | 200219 | AP (A-rated, therapeutically equivalent) | February 13, 2013 | 10USP UNITS/ML (10USP UNITS/ML) |
| SAGENT PHARMACEUTICALS INC | 091676 | AP (A-rated, therapeutically equivalent) | July 13, 2018 | 100USP UNITS/10ML (10USP UNITS/ML), 10USP UNITS/ML (10USP UNITS/ML) |
Pitocin NDC codes
Questions
Is there a generic for Pitocin?
Yes. The generic name for Pitocin is oxytocin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 3 Pitocin products the Orange Book lists.
What is the generic name for Pitocin?
The active ingredient in Pitocin is oxytocin, 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.