FDA Orange Book
Generic for Primacor
Primacor contains milrinone lactate. 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 Primacor is milrinone lactate. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Primacor products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 1MG BASE/ML | Discontinued | None | 7 | AP |
NDA 019436, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic milrinone lactate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 075936 | AP (A-rated, therapeutically equivalent) | May 28, 2002 | EQ 1MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 075660 | AP (A-rated, therapeutically equivalent) | May 28, 2002 | EQ 1MG BASE/ML |
| HIKMA FARMACEUTICA (PORTUGAL) SA | 077966 | AP (A-rated, therapeutically equivalent) | December 3, 2010 | EQ 1MG BASE/ML |
| HOSPIRA INC | 203280 | AP (A-rated, therapeutically equivalent) | September 3, 2014 | EQ 1MG BASE/ML |
| MEITHEAL PHARMACEUTICALS INC | 211671 | AP (A-rated, therapeutically equivalent) | March 24, 2020 | EQ 1MG BASE/ML |
| CAPLIN STERILES LTD | 214380 | AP (A-rated, therapeutically equivalent) | April 16, 2021 | EQ 1MG BASE/ML |
| SHANDONG NEW TIME PHARMACEUTICAL CO LTD | 216373 | AP (A-rated, therapeutically equivalent) | January 23, 2023 | EQ 1MG BASE/ML |
Questions
Is there a generic for Primacor?
Yes. The generic name for Primacor is milrinone lactate. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Primacor?
The active ingredient in Primacor is milrinone lactate, 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.