FDA Orange Book
Is there a generic for Motofen?
Motofen contains difenoxin and atropine. 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 Motofen (difenoxin and atropine).
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Motofen products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.025MG;1MG | Marketed (Rx) | None | 0 | None |
NDA 017744, held by LEGACY PHARMA INC SEZC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Motofen NDC codes
Questions
Is there a generic for Motofen?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Motofen (difenoxin and atropine).
What is the generic name for Motofen?
The active ingredient in Motofen is difenoxin and atropine, 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.
More on Motofen and Difenoxin and Atropine
- What is Motofen used for?FDA label uses
- Is Motofen a controlled substance?Schedule IV
- Is Difenoxin and Atropine a controlled substance?Schedule IV
- Anticholinergics listFDA drug class
- Antidiarrheals listFDA drug class
- Cholinergic Muscarinic Antagonists listFDA drug class
- NDC 54766-200Motofen NDC record
- NDC 83107-011Motofen NDC record
- Schedule IV drugs listDEA schedule