Loperamide Hydrochloride
- Product NDC
- 50090-0460
- 11-digit product format
- 500900460
- Labeler code
- 50090
- Product ID
- 50090-0460_758f74d5-c515-43e7-b4be-2b07007ac83e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA073192
- Marketing category
- ANDA
- Marketing start
- 1993-05-01
- 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 |
|---|
| 50090-0460-0 | 50090046000 | 15 CAPSULE in 1 BOTTLE (50090-0460-0) | 15 capsule | 2016-06-29 | No | No | Historical |
| 50090-0460-3 | 50090046003 | 12 CAPSULE in 1 BOTTLE (50090-0460-3) | 12 capsule | 2016-06-29 | No | No | Historical |
| 50090-0460-4 | 50090046004 | 30 CAPSULE in 1 BOTTLE (50090-0460-4) | 30 capsule | 2016-06-29 | No | No | Historical |