Diphenoxylate Hydrochloride and Atropine Sulfate
- Product NDC
- 70518-3915
- 11-digit product format
- 705183915
- Labeler code
- 70518
- Product ID
- 70518-3915_3ba26cb7-32e1-5652-e063-6394a90a3692
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diphenoxylate hydrochloride and atropine sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA213413
- Marketing category
- ANDA
- Marketing start
- 2023-11-16
- 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 |
|---|
| 70518-3915-1 | 70518391501 | 30 TABLET in 1 BLISTER PACK (70518-3915-1) | 30 tablet | 2024-06-24 | No | No | Historical |