Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 71610-809
- 11-digit product format
- 716100809
- Labeler code
- 71610
- Product ID
- 71610-809_159ed936-248b-38c9-e063-6394a90a0f2a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diphenoxylate hydrochloride and atropine sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA213413
- Marketing category
- ANDA
- Marketing start
- 2020-03-15
- Substance
- ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
- Active strength
- .025; 2.5 mg/1; mg/1
- Pharmacologic classes
- Anticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 03J5ZE7KA5 | ATROPINE SULFATE | 5908-99-6 | ATROPINE SULFATE |
| W24OD7YW48 | DIPHENOXYLATE HYDROCHLORIDE | 3810-80-8 | DIPHENOXYLATE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-809-53 | 71610080953 | 60 TABLET in 1 BOTTLE (71610-809-53) | 60 tablet | 2024-03-22 | No | No | Historical |
| 71610-809-60 | 71610080960 | 90 TABLET in 1 BOTTLE (71610-809-60) | 90 tablet | 2024-03-22 | No | No | Historical |
| 71610-809-70 | 71610080970 | 120 TABLET in 1 BOTTLE (71610-809-70) | 120 tablet | 2024-03-22 | No | No | Historical |
| 71610-809-80 | 71610080980 | 180 TABLET in 1 BOTTLE (71610-809-80) | 180 tablet | 2024-04-08 | No | No | Historical |
| 71610-809-90 | 71610080990 | 240 TABLET in 1 BOTTLE (71610-809-90) | 240 tablet | 2024-04-08 | No | No | Historical |