FDA Orange Book
Generic for Norflex
Norflex contains orphenadrine. 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 Norflex is orphenadrine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Norflex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 30MG/ML | Discontinued | None | 4 | AP |
| tablet, extended release, oral | 100MG | Discontinued | None | 4 | AB |
NDA 013055, 012157, 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 orphenadrine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 084779 | AP (A-rated, therapeutically equivalent) | March 15, 1982 | 30MG/ML |
| LUPIN INC | 040284 | AB (A-rated, therapeutically equivalent) | June 19, 1998 | 100MG |
| RISING PHARMA HOLDINGS INC | 040249 | AB (A-rated, therapeutically equivalent) | January 29, 1999 | 100MG |
| SANDOZ INC | 040327 | AB (A-rated, therapeutically equivalent) | February 15, 2000 | 100MG |
| HIKMA PHARMACEUTICALS USA INC | 040463 | AP (A-rated, therapeutically equivalent) | March 4, 2003 | 30MG/ML |
| RISING PHARMA HOLDINGS INC | 040484 | AP (A-rated, therapeutically equivalent) | May 24, 2006 | 30MG/ML |
| SAGENT PHARMACEUTICALS INC | 090585 | AP (A-rated, therapeutically equivalent) | August 30, 2011 | 30MG/ML |
| UNICHEM LABORATORIES LTD | 091158 | AB (A-rated, therapeutically equivalent) | July 27, 2012 | 100MG |
Questions
Is there a generic for Norflex?
Yes. The generic name for Norflex is orphenadrine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Norflex?
The active ingredient in Norflex is orphenadrine, 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.