Last updated: May 28, 2026
Who are the FDA-approved manufacturers and suppliers for Lomotil (diphenoxylate hydrochloride/atropine sulfate)?
Lomotil is a prescription antidiarrheal combination product containing diphenoxylate hydrochloride and atropine sulfate. Supplier coverage for this specific branded product depends on the current FDA label manufacturer and Orange Book listed application holders for the relevant NDC(s).
Actionable answer: Without an NDC-specific label source, it is not possible to provide a complete, accurate supplier list (manufacturers, packagers, or contract manufacturing partners) for “Lomotil” across strengths and package sizes.
Which companies supply generic diphenoxylate/atropine hydrochloride products in the U.S.?
Generic “diphenoxylate and atropine” suppliers change as ANDAs are approved, acquired, and relabeled under different application holders. The correct way to build a supplier map is to pull Orange Book listings by active ingredient strength and dosage form, then cross-check FDA label “Manufactured for” and “Distributed by” sections by NDC.
Actionable answer: A generic supplier list requires Orange Book + NDC data for the product’s specific strengths and dosage form.
What does the Lomotil label say about “manufactured for,” “distributed by,” and contract manufacturing?
Lomotil sourcing is typically represented on the FDA label in three separate fields:
- Manufacturing site name and address (often a contracted facility)
- Application holder / labeler (company that holds the marketed product responsibility)
- Distributor (which may differ from the manufacturer)
Actionable answer: Supplier identification is label-driven and must be compiled from the current package insert tied to each NDC.
How do you map Lomotil suppliers by NDC and strength?
To convert “Lomotil” into a supplier roster, the workflow is:
- Identify all Lomotil NDCs for tablets (and any liquid formulation if applicable).
- For each NDC, pull:
- Orange Book entry (application holder)
- FDA label “Manufactured for” and “Distributed by”
- Any listed manufacturing/packaging sites
Actionable answer: A supplier list cannot be completed without specifying the exact dosage form and NDCs.
Which manufacturing partners commonly produce diphenoxylate/atropine products?
Contract manufacturing for older, low-complexity oral solid dose combinations is frequently done by third-party manufacturers and packagers. However, naming partners as “suppliers” for Lomotil requires confirmed label or FDA registration evidence.
Actionable answer: No verified, NDC-linked contract manufacturers can be stated without current label/NDC extraction.
What procurement and supply-risk checks should be run for Lomotil sourcing?
For procurement, the relevant high-signal checks are:
- Application holder continuity: does the labeler match the Orange Book applicant?
- Site changes: manufacturing address updates across label versions
- Regulatory changes: manufacturing supplements, ongoing inspections
- Availability constraints: backorders tied to specific sites or dosage strength
Actionable answer: Supplier identification and supply-risk analysis are both NDC- and site-specific.
Key Takeaways
- “Lomotil suppliers” is not a single list. It must be built by NDC, strength, and dosage form using the current FDA label and Orange Book.
- A complete supplier roster cannot be produced from the drug name alone without NDC-linked label and Orange Book data.
FAQs
- How can I identify the current manufacturer for Lomotil for a specific NDC?
- Are generic diphenoxylate/atropine suppliers the same as the Orange Book application holders?
- Do manufacturing sites change for Lomotil across label revisions?
- How do shortages for antidiarrheal oral tablets differ by NDC strength?
- What’s the fastest way to build a supplier map for diphenoxylate/atropine across multiple NDCs?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- U.S. Food and Drug Administration. Drug Labels (Prescribing Information) for Lomotil (diphenoxylate hydrochloride and atropine sulfate).
