Prescription drug · ANDA
Diphenoxylate Hydrochloride and Atropine Sulfate NDC 60687-890
Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-890-01 | 60687089001 | 100 BLISTER PACK in 1 CARTON (60687-890-01) / 1 TABLET in 1 BLISTER PACK (60687-890-11)Marketed from Aug 1, 2025 |
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)
- 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
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213335
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 60687-890_3b296539-820e-5b71-e063-6394a90ab6d9SPL ID 3b296539-820e-5b71-e063-6394a90ab6d9SPL set ID d0a1c80d-6aae-4886-8c25-e2d29ca0836bRxCUI 1190572UNII 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
N460687089001followed by a unit qualifier and the quantityPackage 60687-0890-01. 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 tablets are 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 ANDA 213335
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 | SpecGx LLC | 0406-1236 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-714 |