FDA Orange Book
Generic for Narcan
Narcan contains naloxone. 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 Narcan is naloxone. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 4 Narcan products the Orange Book lists.
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Narcan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 0.02MG/ML | Discontinued | None | 0 | None |
| injectable, injection | 0.4MG/ML | Discontinued | None | 19 | AP |
| injectable, injection | 1MG/ML | Discontinued | None | 11 | AP |
| spray, metered, nasal | 2MG/SPRAY | Discontinued | None | 0 | None |
NDA 016636, 208411, held by ADAPT PHARMA OPERATIONS LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic naloxone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 070299 | AP (A-rated, therapeutically equivalent) | September 24, 1986 | 0.4MG/ML |
| HOSPIRA INC | 070172 | AP (A-rated, therapeutically equivalent) | September 24, 1986 | 0.4MG/ML |
| HOSPIRA INC | 070256 | AP (A-rated, therapeutically equivalent) | January 7, 1987 | 0.4MG/ML |
| HOSPIRA INC | 070257 | AP (A-rated, therapeutically equivalent) | January 7, 1987 | 0.4MG/ML |
| INTERNATIONAL MEDICATION SYSTEM | 072076 | AP (A-rated, therapeutically equivalent) | March 24, 1988 | 1MG/ML |
| MYLAN INSTITUTIONAL LLC | 204997 | AP (A-rated, therapeutically equivalent) | March 6, 2014 | 0.4MG/ML |
| MYLAN INSTITUTIONAL LLC | 205014 | AP (A-rated, therapeutically equivalent) | June 29, 2016 | 0.4MG/ML |
| RISING PHARMA HOLDINGS INC | 208871 | AP (A-rated, therapeutically equivalent) | February 28, 2017 | 0.4MG/ML |
| RISING PHARMA HOLDINGS INC | 208872 | AP (A-rated, therapeutically equivalent) | March 14, 2017 | 0.4MG/ML |
| SOMERSET THERAPEUTICS LLC | 207634 | AP (A-rated, therapeutically equivalent) | July 26, 2017 | 0.4MG/ML |
| SOMERSET THERAPEUTICS LLC | 207633 | AP (A-rated, therapeutically equivalent) | August 8, 2017 | 0.4MG/ML |
| EUGIA PHARMA SPECIALITIES LTD | 212456 | AP (A-rated, therapeutically equivalent) | November 4, 2019 | 0.4MG/ML |
| DR REDDYS LABORATORIES LTD | 213209 | AP (A-rated, therapeutically equivalent) | March 16, 2020 | 1MG/ML |
| EUGIA PHARMA SPECIALITIES LTD | 213279 | AP (A-rated, therapeutically equivalent) | January 14, 2021 | 1MG/ML |
| BAXTER HEALTHCARE CORP | 214785 | AP (A-rated, therapeutically equivalent) | January 29, 2021 | 0.4MG/ML, 1MG/ML |
| MYLAN LABORATORIES LTD | 213843 | AP (A-rated, therapeutically equivalent) | June 9, 2022 | 1MG/ML |
| PH HEALTH LTD | 215964 | AP (A-rated, therapeutically equivalent) | July 29, 2022 | 1MG/ML |
| ACCORD HEALTHCARE INC | 216624 | AP (A-rated, therapeutically equivalent) | October 26, 2022 | 0.4MG/ML, 1MG/ML |
| BAXTER HEALTHCARE CORP | 214792 | AP (A-rated, therapeutically equivalent) | November 7, 2022 | 0.4MG/ML |
| BPI LABS LLC | 216977 | AP (A-rated, therapeutically equivalent) | October 6, 2023 | 1MG/ML |
| MANKIND PHARMA LTD | 218404 | AP (A-rated, therapeutically equivalent) | February 29, 2024 | 0.4MG/ML |
| HIKMA PHARMACEUTICALS USA INC | 212300 | AP (A-rated, therapeutically equivalent) | March 7, 2024 | 0.4MG/ML, 1MG/ML |
| FRESENIUS KABI USA LLC | 213573 | AP (A-rated, therapeutically equivalent) | April 2, 2024 | 0.4MG/ML, 1MG/ML |
| STERINOVA INC | 214211 | AP (A-rated, therapeutically equivalent) | August 21, 2025 | 0.4MG/ML |
| STERINOVA INC | 219942 | AP (A-rated, therapeutically equivalent) | August 18, 2026 | 0.4MG/ML, 1MG/ML |
Narcan NDC codes
Questions
Is there a generic for Narcan?
Yes. The generic name for Narcan is naloxone. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 2 of the 4 Narcan products the Orange Book lists.
What is the generic name for Narcan?
The active ingredient in Narcan is naloxone, 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.
More on Narcan and Naloxone
- What is Narcan used for?FDA label uses
- Is Narcan a controlled substance?Federal schedule
- What is Naloxone used for?FDA label uses
- Is Naloxone a controlled substance?Federal schedule
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- Opioid Antagonists listFDA drug class
- NDC 50090-2422Narcan NDC record
- NDC 69547-353Narcan NDC record
- NDC 71205-528Narcan NDC record