LOPERAMIDE HYDROCHLORIDE
- Product NDC
- 68071-3618
- 11-digit product format
- 680713618
- Labeler code
- 68071
- Product ID
- 68071-3618_200c6126-b08d-7aa4-e063-6394a90ab9db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LOPERAMIDE HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA218122
- Marketing category
- ANDA
- Marketing start
- 2023-09-05
- 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 |
|---|
| 68071-3618-1 | 68071361801 | 12 CAPSULE in 1 BOTTLE (68071-3618-1) | 12 capsule | 2024-06-14 | No | No | Historical |
| 68071-3618-2 | 68071361802 | 20 CAPSULE in 1 BOTTLE (68071-3618-2) | 20 capsule | 2024-06-14 | No | No | Historical |