Prescription drug · ANDA
Diphenoxylate Hydrochloride and Atropine Sulfate NDC 0054-3194
Diphenoxylate hydrochloride 2.5 mg/5mL; Atropine sulfate .025 mg/5mL · Solution · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-3194-46 | 00054319446 | 1 BOTTLE in 1 CARTON (0054-3194-46) / 60 mL in 1 BOTTLEMarketed from May 3, 1982 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Diphenoxylate Hydrochloride and Atropine Sulfate
- Generic name (nonproprietary)
- diphenoxylate hydrochloride and atropine sulfate
- Active ingredients
- Diphenoxylate hydrochloride — 2.5 mg/5mLAtropine sulfate — .025 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 087708
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 0054-3194_6eba0e62-fd1b-4f1b-bf47-7ea47f04ad7aSPL ID 6eba0e62-fd1b-4f1b-bf47-7ea47f04ad7aSPL set ID 88ed4ccf-9e35-4142-a5eb-d2b5edd36956RxCUI 1190568UNII W24OD7YW48, 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
N400054319446followed by a unit qualifier and the quantityPackage 00054-3194-46. 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.