Prescription drug · NDA
Motofen (Difenoxin and atropine sulfate) NDC 83107-011
Difenoxin hydrochloride 1 mg/1; Atropine sulfate .025 mg/1 · Tablet · Oral · Legacy Pharma USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83107-011-10 | 8310700111083107001110 | 100 TABLET in 1 BOTTLE (83107-011-10)Marketed from Jan 1, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Motofen
- Generic name (nonproprietary)
- difenoxin and atropine sulfate
- Active ingredients
- Difenoxin hydrochloride — 1 mg/1Atropine sulfate — .025 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Legacy Pharma USA Inc.NDC labeler code 83107
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017744
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 83107-011_4db25dab-3394-5f06-e063-6294a90a9688SPL ID 4db25dab-3394-5f06-e063-6294a90a9688SPL set ID 1fa11c67-5492-469c-9475-6bfa0e5e9ff8RxCUI 1190738, 1190740UNII VQZ63K01IW, 03J5ZE7KA5
- Pharmacologic class
- Anticholinergic; Antidiarrheal; Cholinergic Muscarinic Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N483107001110followed by a unit qualifier and the quantityPackage 83107-0011-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE MOTOFEN ® is indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.
Excerpt only. Read the full label for complete information.
About NDC 83107-011
- What is NDC 83107-011?
- 83107-011 is the product NDC for Motofen, Difenoxin hydrochloride 1 mg/1; Atropine sulfate .025 mg/1 tablet, listed with the FDA by Legacy Pharma USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Motofen (Difenoxin and atropine sulfate).
- What is the active ingredient?
- Difenoxin hydrochloride, Atropine sulfate.
- Who is the labeler?
- Legacy Pharma USA Inc., NDC labeler code 83107. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Motofen?
- 1 other product NDC are listed under this name. See all Motofen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Motofen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Motofendifenoxin and atropine sulfate | Difenoxin hydrochloride 1 mg/1; Atropine sulfate .025 mg/1 | TabletOral | Sebela Pharmaceuticals Inc. | 54766-200 | 54766-0200-10 |
Other NDCs under NDA 017744
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Motofendifenoxin and atropine sulfate | Difenoxin hydrochloride 1 mg/1; Atropine sulfate .025 mg/1 | TabletOral | Sebela Pharmaceuticals Inc. | 54766-200 |