FDA Orange Book
Generic for Aquamephyton
Aquamephyton contains phytonadione. 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 Aquamephyton is phytonadione. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2, BP.
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Aquamephyton products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 10MG/ML | Discontinued | None | 7 | AB1 |
| injectable, injection | 1MG/0.5ML | Discontinued | None | 10 | AB1, BP, AB2 |
NDA 012223, held by PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic phytonadione
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HOSPIRA INC | 087955 | AB1 (A-rated, therapeutically equivalent) | July 25, 1983 | 10MG/ML |
| HOSPIRA INC | 087954 | BP (B-rated, not considered equivalent) | July 25, 1983 | 1MG/0.5ML |
| DR REDDYS LABORATORIES LTD | 207719 | AB1 (A-rated, therapeutically equivalent) | May 22, 2019 | 10MG/ML |
| CIPLA LTD | 214596 | None (No TE code listed) | April 22, 2022 | 10MG/ML, 1MG/0.5ML |
| GLAND PHARMA LTD | 217386 | AB1 (A-rated, therapeutically equivalent) | December 10, 2024 | 10MG/ML |
| CIPLA LTD | 214966 | AB1 (A-rated, therapeutically equivalent) | January 3, 2025 | 1MG/0.5ML |
| CAPLIN STERILES LTD | 219212 | AB1 (A-rated, therapeutically equivalent) | April 17, 2025 | 10MG/ML |
| ALEMBIC PHARMACEUTICALS LTD | 216444 | AB1 (A-rated, therapeutically equivalent) | September 8, 2025 | 1MG/0.5ML |
| AMNEAL EU LTD | 216601 | AB1 (A-rated, therapeutically equivalent) | November 4, 2025 | 1MG/0.5ML |
| SUNNY PHARMTECH INC | 215090 | AB1 (A-rated, therapeutically equivalent) | January 9, 2026 | 10MG/ML |
| BAXTER HEALTHCARE CORP | 216852 | AB2 (A-rated, therapeutically equivalent) | February 26, 2026 | 1MG/0.5ML |
| ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LTD | 216298 | AB1 (A-rated, therapeutically equivalent) | March 13, 2026 | 1MG/0.5ML |
| DR REDDYS LABORATORIES LTD | 215820 | AB1 (A-rated, therapeutically equivalent) | May 15, 2026 | 1MG/0.5ML |
| AMNEAL EU LTD | 217734 | AB1 (A-rated, therapeutically equivalent) | June 1, 2026 | 10MG/ML |
| LUPIN LTD | 219175 | AB2 (A-rated, therapeutically equivalent) | September 30, 2026 | 1MG/0.5ML |
| INTERNATIONAL MEDICATION SYSTEM | 083722 | AB1 (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 1MG/0.5ML |
Questions
Is there a generic for Aquamephyton?
Yes. The generic name for Aquamephyton is phytonadione. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2, BP.
What is the generic name for Aquamephyton?
The active ingredient in Aquamephyton is phytonadione, 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.