FDA Orange Book
Generic for Sular
Sular contains nisoldipine. 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 Sular is nisoldipine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 8 Sular products the Orange Book lists.
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Sular products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 10MG | Discontinued | None | 0 | None |
| tablet, extended release, oral | 17MG | Discontinued | None | 1 | None |
| tablet, extended release, oral | 20MG | Discontinued | None | 0 | None |
| tablet, extended release, oral | 25.5MG | Discontinued | None | 0 | None |
| tablet, extended release, oral | 30MG | Discontinued | None | 0 | None |
| tablet, extended release, oral | 34MG | Discontinued | None | 0 | None |
| tablet, extended release, oral | 40MG | Discontinued | None | 0 | None |
| tablet, extended release, oral | 8.5MG | Marketed (Rx) | AB | 1 | AB |
NDA 020356, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic nisoldipine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMTA LABS LTD | 216606 | None (No TE code listed) | December 12, 2025 | 17MG, 8.5MG |
Sular NDC codes
Questions
Is there a generic for Sular?
Yes. The generic name for Sular is nisoldipine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 8 Sular products the Orange Book lists.
What is the generic name for Sular?
The active ingredient in Sular is nisoldipine, 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.