Loperamide Hydrochloride
- Product NDC
- 50268-482
- 11-digit product format
- 502680482
- Labeler code
- 50268
- Product ID
- 50268-482_2b49645c-34d1-c6ab-e063-6394a90aaee5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- loperamide hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA215579
- Marketing category
- ANDA
- Marketing start
- 2023-04-05
- 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 |
|---|
| 50268-482-15 | 50268048215 | 50 BLISTER PACK in 1 BOX (50268-482-15) / 1 CAPSULE in 1 BLISTER PACK (50268-482-11) | 50 blister pack | 2023-04-05 | No | No | Historical |