Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 72162-1765
- 11-digit product format
- 721621765
- Labeler code
- 72162
- Product ID
- 72162-1765_c4ae838c-25be-44fe-a54f-03495568e258
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diphenoxylate Hydrochloride and Atropine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA086727
- Marketing category
- ANDA
- Marketing start
- 2017-07-07
- 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 |
|---|
| 72162-1765-0 | 72162176500 | 1000 TABLET in 1 BOTTLE (72162-1765-0) | 1000 tablet | 2024-02-01 | No | No | Historical |
| 72162-1765-1 | 72162176501 | 100 TABLET in 1 BOTTLE (72162-1765-1) | 100 tablet | 2024-02-01 | No | No | Historical |