Prescription drug · ANDA
Diphenoxylate Hydrochloride and Atropine Sulfate NDC 43353-594
Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43353-594-30 | 43353059430 | 30 TABLET in 1 BOTTLE (43353-594-30)Marketed from Jul 26, 2017 | |
| 43353-594-53 | 43353059453 | 60 TABLET in 1 BOTTLE (43353-594-53)Marketed from Jul 26, 2017 | |
| 43353-594-60 | 43353059460 | 90 TABLET in 1 BOTTLE (43353-594-60)Marketed from Jul 26, 2017 | |
| 43353-594-70 | 43353059470 | 120 TABLET in 1 BOTTLE (43353-594-70)Marketed from Jul 26, 2017 | |
| 43353-594-80 | 43353059480 | 180 TABLET in 1 BOTTLE (43353-594-80)Marketed from Jul 26, 2017 | |
| 43353-594-90 | 43353059490 | 240 TABLET in 1 BOTTLE (43353-594-90)Marketed from Jul 26, 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)
- 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 086727
- Marketing start
- Listing expires
- DEA schedule
- CV
- Other FDA classes
- Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 43353-594_ef69e563-7239-4c78-8fb4-3cd641fbff17SPL ID ef69e563-7239-4c78-8fb4-3cd641fbff17SPL set ID 435e5e75-5a4c-4806-8d9e-d4be3fef9229RxCUI 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
N443353059430followed by a unit qualifier and the quantityPackage 43353-0594-30. 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 USP are effective as adjunctive therapy in the management of diarrhea.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 086727
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 | Bryant Ranch Prepack | 71335-0311 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | A-S Medication Solutions | 50090-3456 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-490 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4063 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | Diphenoxylate hydrochloride 2.5 mg/1; Atropine sulfate .025 mg/1 | TabletOral | Proficient Rx LP | 63187-939 |