Loperamide Hydrochloride
- Product NDC
- 71610-950
- 11-digit product format
- 716100950
- Labeler code
- 71610
- Product ID
- 71610-950_3f031e70-1ec5-6787-e063-6294a90a61de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA215001
- Marketing category
- ANDA
- Marketing start
- 2021-10-06
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 77TI35393C | LOPERAMIDE HYDROCHLORIDE | 34552-83-5 | LOPERAMIDE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-950-30 | 71610095030 | 30 CAPSULE in 1 BOTTLE (71610-950-30) | 30 capsule | 2025-09-17 | No | No | Historical |
| 71610-950-53 | 71610095053 | 60 CAPSULE in 1 BOTTLE (71610-950-53) | 60 capsule | 2025-09-17 | No | No | Historical |
| 71610-950-60 | 71610095060 | 90 CAPSULE in 1 BOTTLE (71610-950-60) | 90 capsule | 2025-09-17 | No | No | Historical |
| 71610-950-80 | 71610095080 | 180 CAPSULE in 1 BOTTLE (71610-950-80) | 180 capsule | 2025-09-17 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Loperamide Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | 2025-09-17 | HUMAN PRESCRIPTION DRUG LABEL | 1 |