FDA Orange Book
Generic for Symmetrel
Symmetrel contains amantadine. 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 Symmetrel is amantadine. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
Run it in Rivvi
Map Symmetrel and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Symmetrel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Discontinued | None | 11 | AB |
| syrup, oral | 50MG/5ML | Discontinued | None | 5 | AA |
| tablet, oral | 100MG | Discontinued | None | 5 | AB |
NDA 016020, 016023, 018101, held by ENDO PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic amantadine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| UPSHER SMITH LABORATORIES LLC | 070589 | AB (A-rated, therapeutically equivalent) | August 5, 1986 | 100MG |
| SANDOZ INC | 071293 | AB (A-rated, therapeutically equivalent) | February 18, 1987 | 100MG |
| CHARTWELL RX SCIENCES LLC | 074028 | AA (A-rated, therapeutically equivalent) | June 28, 1993 | 50MG/5ML |
| AUROBINDO PHARMA USA INC | 074170 | AA (A-rated, therapeutically equivalent) | October 28, 1994 | 50MG/5ML |
| PHARMACEUTICAL ASSOCIATES INC | 074509 | AA (A-rated, therapeutically equivalent) | July 17, 1995 | 50MG/5ML |
| PHARMOBEDIENT CONSULTING LLC | 075060 | AA (A-rated, therapeutically equivalent) | December 24, 1998 | 50MG/5ML |
| UPSHER SMITH LABORATORIES LLC | 076186 | AB (A-rated, therapeutically equivalent) | December 16, 2002 | 100MG |
| BIONPHARMA INC | 078720 | AB (A-rated, therapeutically equivalent) | May 29, 2008 | 100MG |
| ZYDUS PHARMACEUTICALS USA INC | 208278 | AB (A-rated, therapeutically equivalent) | May 31, 2016 | 100MG |
| STRIDES PHARMA GLOBAL PTE LTD | 209047 | AB (A-rated, therapeutically equivalent) | June 7, 2017 | 100MG |
| STRIDES PHARMA GLOBAL PTE LTD | 209035 | AB (A-rated, therapeutically equivalent) | June 9, 2017 | 100MG |
| HERITAGE PHARMA LABS INC | 209171 | AB (A-rated, therapeutically equivalent) | June 12, 2017 | 100MG |
| ALEMBIC PHARMACEUTICALS LTD | 208966 | AB (A-rated, therapeutically equivalent) | June 21, 2017 | 100MG |
| RISING PHARMA HOLDINGS INC | 210129 | AB (A-rated, therapeutically equivalent) | March 2, 2020 | 100MG |
| PHARMOBEDIENT CONSULTING LLC | 210215 | AB (A-rated, therapeutically equivalent) | March 10, 2020 | 100MG |
| RUBICON RESEARCH LTD | 212044 | AB (A-rated, therapeutically equivalent) | May 21, 2020 | 100MG |
| ALEMBIC PHARMACEUTICALS LTD | 214284 | AB (A-rated, therapeutically equivalent) | October 15, 2020 | 100MG |
| PHARMOBEDIENT CONSULTING LLC | 214178 | AA (A-rated, therapeutically equivalent) | August 20, 2021 | 50MG/5ML |
| ONESOURCE SOFTGELS PTE LTD | 211354 | AB (A-rated, therapeutically equivalent) | February 18, 2022 | 100MG |
| HUMANWELL PURACAP PHARMACEUTICAL WUHAN CO LTD | 214580 | AB (A-rated, therapeutically equivalent) | December 20, 2022 | 100MG |
| ZHEJIANG JUTAI PHARMACEUTICAL CO LTD | 218598 | AB (A-rated, therapeutically equivalent) | September 26, 2024 | 100MG |
Questions
Is there a generic for Symmetrel?
Yes. The generic name for Symmetrel is amantadine. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
What is the generic name for Symmetrel?
The active ingredient in Symmetrel is amantadine, 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.