FDA Orange Book
Generic for Norpace
Norpace contains disopyramide. 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 Norpace is disopyramide. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Norpace products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 100MG BASE | Marketed (Rx) | AB | 2 | AB |
| capsule, oral | EQ 150MG BASE | Marketed (Rx) | AB | 2 | AB |
NDA 017447, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic disopyramide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 070101 | AB (A-rated, therapeutically equivalent) | February 22, 1985 | EQ 100MG BASE |
| TEVA PHARMACEUTICALS USA INC | 070102 | AB (A-rated, therapeutically equivalent) | February 22, 1985 | EQ 150MG BASE |
| DR REDDYS LABORATORIES SA | 070173 | AB (A-rated, therapeutically equivalent) | May 31, 1985 | EQ 100MG BASE, EQ 150MG BASE |
Norpace NDC codes
Questions
Is there a generic for Norpace?
Yes. The generic name for Norpace is disopyramide. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Norpace?
The active ingredient in Norpace is disopyramide, 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.