FDA Orange Book
Generic for Levophed
Levophed contains norepinephrine. 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 Levophed is norepinephrine. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Levophed products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 1MG BASE/ML | Marketed (Rx) | AP | 16 | AP |
NDA 007513, held by HOSPIRA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic norepinephrine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MEITHEAL PHARMACEUTICALS INC | 040455 | AP (A-rated, therapeutically equivalent) | March 3, 2003 | EQ 1MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 040462 | AP (A-rated, therapeutically equivalent) | October 31, 2003 | EQ 1MG BASE/ML |
| BAXTER HEALTHCARE CORP | 040859 | AP (A-rated, therapeutically equivalent) | March 27, 2012 | EQ 1MG BASE/ML |
| MYLAN LABORATORIES LTD | 211242 | AP (A-rated, therapeutically equivalent) | October 4, 2018 | EQ 1MG BASE/ML |
| SANDOZ INC | 211359 | AP (A-rated, therapeutically equivalent) | October 18, 2018 | EQ 1MG BASE/ML |
| HIKMA FARMACEUTICA PORTUGAL SA | 203662 | AP (A-rated, therapeutically equivalent) | November 7, 2018 | EQ 1MG BASE/ML |
| FRESENIUS KABI USA LLC | 211382 | AP (A-rated, therapeutically equivalent) | November 3, 2020 | EQ 1MG BASE/ML |
| BRECKENRIDGE PHARMACEUTICAL INC | 214455 | AP (A-rated, therapeutically equivalent) | January 22, 2021 | EQ 1MG BASE/ML |
| GLAND PHARMA LTD | 214323 | AP (A-rated, therapeutically equivalent) | May 6, 2021 | EQ 1MG BASE/ML |
| CAPLIN STERILES LTD | 217575 | AP (A-rated, therapeutically equivalent) | September 15, 2023 | EQ 1MG BASE/ML |
| RISING PHARMA HOLDINGS INC | 218758 | AP (A-rated, therapeutically equivalent) | May 13, 2024 | EQ 1MG BASE/ML |
| ASPIRO PHARMA LTD | 219163 | AP (A-rated, therapeutically equivalent) | January 31, 2025 | EQ 1MG BASE/ML |
| BIOCON PHARMA LTD | 219443 | AP (A-rated, therapeutically equivalent) | March 21, 2025 | EQ 1MG BASE/ML |
| ADAPTIS PHARMA PRIVATE LTD | 219924 | AP (A-rated, therapeutically equivalent) | November 25, 2025 | EQ 1MG BASE/ML |
| MSN LABORATORIES PRIVATE LTD | 218595 | AP (A-rated, therapeutically equivalent) | December 11, 2025 | EQ 1MG BASE/ML |
| NEPHRON PHARMACEUTICALS CORPORATION | 216272 | AP (A-rated, therapeutically equivalent) | June 11, 2026 | EQ 1MG BASE/ML |
Levophed NDC codes
Questions
Is there a generic for Levophed?
Yes. The generic name for Levophed is norepinephrine. 16 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 Levophed?
The active ingredient in Levophed is norepinephrine, 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.