FDA Orange Book
Generic for Lipo-hepin
Lipo-hepin contains heparin. 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 Lipo-hepin is heparin. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 4 of the 11 Lipo-hepin products the Orange Book lists.
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Lipo-hepin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 1,000 UNITS/0.5ML | Discontinued | None | 0 | None |
| injectable, injection | 1,000 UNITS/ML | Discontinued | None | 11 | AP |
| injectable, injection | 10,000 UNITS/0.5ML | Discontinued | None | 0 | None |
| injectable, injection | 10,000 UNITS/ML | Discontinued | None | 9 | AP |
| injectable, injection | 15,000 UNITS/0.5ML | Discontinued | None | 0 | None |
| injectable, injection | 20,000 UNITS/0.5ML | Discontinued | None | 0 | None |
| injectable, injection | 20,000 UNITS/ML | Discontinued | None | 3 | AP |
| injectable, injection | 40,000 UNITS/ML | Discontinued | None | 0 | None |
| injectable, injection | 5,000 UNITS/0.5ML | Discontinued | None | 0 | None |
| injectable, injection | 5,000 UNITS/ML | Discontinued | None | 11 | AP |
| injectable, injection | 7,500 UNITS/0.5ML | Discontinued | None | 0 | None |
NDA 017027, held by 3M PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic heparin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HOSPIRA INC | 088100 | None (No TE code listed) | April 28, 1983 | 5,000 UNITS/ML |
| HOSPIRA INC | 089522 | AP (A-rated, therapeutically equivalent) | May 4, 1987 | 10,000 UNITS/ML |
| HOSPIRA INC | 090571 | AP (A-rated, therapeutically equivalent) | August 31, 2009 | 1,000 UNITS/ML, 10,000 UNITS/ML, 5,000 UNITS/ML |
| SAGENT PHARMACEUTICALS INC | 090808 | AP (A-rated, therapeutically equivalent) | June 30, 2010 | 1,000 UNITS/ML, 10,000 UNITS/ML, 5,000 UNITS/ML |
| SAGENT PHARMACEUTICALS INC | 090810 | AP (A-rated, therapeutically equivalent) | June 30, 2010 | 1,000 UNITS/ML |
| SAGENT PHARMACEUTICALS INC | 090809 | AP (A-rated, therapeutically equivalent) | June 30, 2010 | 20,000 UNITS/ML |
| PLANO PHARMACEUTICALS INC | 091682 | AP (A-rated, therapeutically equivalent) | June 8, 2011 | 1,000 UNITS/ML, 5,000 UNITS/ML |
| PLANO PHARMACEUTICALS INC | 201002 | AP (A-rated, therapeutically equivalent) | June 8, 2011 | 10,000 UNITS/ML |
| SHENZHEN TECHDOW PHARMACEUTICAL CO LTD | 202957 | AP (A-rated, therapeutically equivalent) | June 12, 2014 | 1,000 UNITS/ML, 5,000 UNITS/ML |
| SHENZHEN TECHDOW PHARMACEUTICAL CO LTD | 202732 | AP (A-rated, therapeutically equivalent) | June 12, 2014 | 1,000 UNITS/ML |
| SHENZHEN TECHDOW PHARMACEUTICAL CO LTD | 203198 | AP (A-rated, therapeutically equivalent) | June 12, 2014 | 10,000 UNITS/ML, 20,000 UNITS/ML |
| SHENZHEN TECHDOW PHARMACEUTICAL CO LTD | 202733 | AP (A-rated, therapeutically equivalent) | June 12, 2014 | 5,000 UNITS/ML |
| FRESENIUS KABI USA LLC | 206552 | AP (A-rated, therapeutically equivalent) | June 10, 2016 | 5,000 UNITS/ML |
| PHARMOBEDIENT CONSULTING LLC | 203851 | AP (A-rated, therapeutically equivalent) | November 30, 2017 | 1,000 UNITS/ML, 10,000 UNITS/ML, 5,000 UNITS/ML |
| EMERGE BIOSCIENCE PTE LTD | 211005 | AP (A-rated, therapeutically equivalent) | December 14, 2018 | 1,000 UNITS/ML |
| EMERGE BIOSCIENCE PTE LTD | 211007 | AP (A-rated, therapeutically equivalent) | May 28, 2019 | 1,000 UNITS/ML, 10,000 UNITS/ML, 5,000 UNITS/ML |
| GLAND PHARMA LTD | 205323 | AP (A-rated, therapeutically equivalent) | November 18, 2019 | 1,000 UNITS/ML, 5,000 UNITS/ML |
| EMERGE BIOSCIENCE PTE LTD | 211004 | AP (A-rated, therapeutically equivalent) | February 24, 2020 | 20,000 UNITS/ML |
| EMERGE BIOSCIENCE PTE LTD | 212060 | AP (A-rated, therapeutically equivalent) | April 2, 2020 | 10,000 UNITS/ML |
| EMERGE BIOSCIENCE PTE LTD | 212061 | AP (A-rated, therapeutically equivalent) | July 15, 2020 | 5,000 UNITS/ML |
| BE PHARMACEUTICALS AG | 214804 | AP (A-rated, therapeutically equivalent) | December 29, 2020 | 1,000 UNITS/ML |
| BE PHARMACEUTICALS AG | 214839 | AP (A-rated, therapeutically equivalent) | December 29, 2020 | 10,000 UNITS/ML |
Questions
Is there a generic for Lipo-hepin?
Yes. The generic name for Lipo-hepin is heparin. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 4 of the 11 Lipo-hepin products the Orange Book lists.
What is the generic name for Lipo-hepin?
The active ingredient in Lipo-hepin is heparin, 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.