FDA Orange Book
Is there a generic for Nicotrol?
Nicotrol contains nicotine. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nicotrol (nicotine).
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Nicotrol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| film, extended release, transdermal | 15MG/16HR | Discontinued | None | 0 | None |
| inhalant, oral | 4MG/CARTRIDGE | Discontinued | None | 0 | None |
| spray, metered, nasal | 0.5MG/SPRAY | Marketed (Rx) | None | 0 | None |
NDA 020536, 020714, 020385, held by MCNEIL CONSUMER HEALTHCARE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Nicotrol NDC codes
Questions
Is there a generic for Nicotrol?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nicotrol (nicotine).
What is the generic name for Nicotrol?
The active ingredient in Nicotrol is nicotine, 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.