Prescription drug · NDA
Motofen (Difenoxin and atropine sulfate) NDC 54766-200
Difenoxin hydrochloride 1 mg/1; Atropine sulfate .025 mg/1 · Tablet · Oral · Sebela Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54766-200-10 | 5476602001054766020010 | 100 TABLET in 1 BOTTLE (54766-200-10)Marketed from Apr 11, 2017 |
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
- Sebela Pharmaceuticals Inc.NDC labeler code 54766
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017744
- Marketing start
- Marketing end
- DEA schedule
- CIV
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 54766-200_43144b43-adf2-3d58-e063-6394a90a2b81SPL ID 43144b43-adf2-3d58-e063-6394a90a2b81SPL set ID 4cd3f029-a5e3-5812-e054-00144ff8d46cRxCUI 1190738, 1190740UNII VQZ63K01IW, 03J5ZE7KA5UPC 0354766200106
- 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
N454766020010followed by a unit qualifier and the quantityPackage 54766-0200-10. 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 54766-200
- What is NDC 54766-200?
- 54766-200 is the product NDC for Motofen, Difenoxin hydrochloride 1 mg/1; Atropine sulfate .025 mg/1 tablet, listed with the FDA by Sebela Pharmaceuticals 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?
- Sebela Pharmaceuticals Inc., NDC labeler code 54766. 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 | Legacy Pharma USA Inc. | 83107-011 | 83107-0011-10 |
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 | Legacy Pharma USA Inc. | 83107-011 |