Prescription drug · NDA AUTHORIZED GENERIC
Diphenoxylate Hydrochloride and Atropine Sulfate NDC 59762-1061
Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 · Tablet · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59762-1061-1 | 59762106101 | 100 TABLET in 1 BOTTLE (59762-1061-1)Marketed from Aug 7, 2012 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Diphenoxylate Hydrochloride and Atropine Sulfate
- Generic name (nonproprietary)
- diphenoxylate hydrochloride and atropine sulfate
- Active ingredients
- Diphenoxylate hydrochloride — 2.5 mg/1Atropine sulfate — .025 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 012462
- Marketing start
- Marketing end
- DEA schedule
- CV
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 59762-1061_b4b0055f-415c-49fa-9c67-cc600ac024beSPL ID b4b0055f-415c-49fa-9c67-cc600ac024beSPL set ID 83bcc2fb-6fb0-4f0e-8e66-592d327684ecRxCUI 1190572UNII W24OD7YW48, 03J5ZE7KA5UPC 0359762106117
- 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
N459762106101followed by a unit qualifier and the quantityPackage 59762-1061-01. 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 Diphenoxylate hydrochloride and atropine sulfate is indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 012462
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 |
|---|---|---|---|---|
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-083 |
| Lomotildiphenoxylate hydrochloride and atropine sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | Pfizer Laboratories Div Pfizer Inc | 0025-0061 |