FDA Orange Book
Generic for Lomotil
Lomotil contains diphenoxylate 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
Yes. The generic name for Lomotil is diphenoxylate and atropine. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Lomotil products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 0.025MG/5ML;2.5MG/5ML | Discontinued | None | 1 | None |
| tablet, oral | 0.025MG;2.5MG | Marketed (Rx) | AA | 7 | AA |
NDA 012699, 012462, held by GD SEARLE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic diphenoxylate and atropine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 087708 | None (No TE code listed) | May 3, 1982 | 0.025MG/5ML;2.5MG/5ML |
| UNICHEM LABORATORIES LTD | 210819 | AA (A-rated, therapeutically equivalent) | November 13, 2018 | 0.025MG;2.5MG |
| LEADING PHARMA LLC | 213413 | AA (A-rated, therapeutically equivalent) | February 20, 2020 | 0.025MG;2.5MG |
| SPECGX LLC | 213335 | AA (A-rated, therapeutically equivalent) | October 6, 2020 | 0.025MG;2.5MG |
| CHARTWELL RX SCIENCES LLC | 207128 | AA (A-rated, therapeutically equivalent) | October 21, 2020 | 0.025MG;2.5MG |
| WINDER LABORATOIRIES LLC | 211362 | AA (A-rated, therapeutically equivalent) | January 27, 2021 | 0.025MG;2.5MG |
| ANI PHARMACEUTICALS INC | 086727 | AA (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 0.025MG;2.5MG |
| LANNETT CO INC | 085372 | AA (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 0.025MG;2.5MG |
Lomotil NDC codes
Questions
Is there a generic for Lomotil?
Yes. The generic name for Lomotil is diphenoxylate and atropine. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Lomotil?
The active ingredient in Lomotil is diphenoxylate 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 Lomotil and Diphenoxylate and Atropine
- What is Lomotil used for?FDA label uses
- Is Lomotil a controlled substance?Schedule V
- What is Diphenoxylate and Atropine used for?FDA label uses
- Is Diphenoxylate and Atropine a controlled substance?Schedule V
- Anticholinergics listFDA drug class
- Antidiarrheals listFDA drug class
- Cholinergic Muscarinic Antagonists listFDA drug class
- NDC 0025-0061Lomotil NDC record
- Schedule V drugs listDEA schedule