Loperamide Hydrochloride
- Product NDC
- 71610-973
- 11-digit product format
- 716100973
- Labeler code
- 71610
- Product ID
- 71610-973_45a1e9d4-58d3-98ef-e063-6394a90aac13
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Loperamide Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOPERAMIDE HYDROCHLORIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 77TI35393C |
| Rxcui | 978006 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-973-53 | Loperamide Hydrochloride | 60 in 1 BOTTLE | CAPSULE | 60 | | 1 |
| 71610-973-60 | Loperamide Hydrochloride | 90 in 1 BOTTLE | CAPSULE | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-973-53 | 71610097353 | 60 CAPSULE in 1 BOTTLE (71610-973-53) | 60 capsule | 2025-12-09 | No | No | Historical |
| 71610-973-60 | 71610097360 | 90 CAPSULE in 1 BOTTLE (71610-973-60) | 90 capsule | 2025-12-09 | No | No | Historical |