Loperamide Hydrochloride
- Product NDC
- 55910-155
- 11-digit product format
- 559100155
- Labeler code
- 55910
- Product ID
- 55910-155_4db35024-40dc-22ee-e063-6394a90a0946
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- DOLGENCORP INC
- Application
- ANDA220100
- Marketing category
- ANDA
- Marketing start
- 2026-03-30
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 1 mg/7.5mL
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Loperamide Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOPERAMIDE HYDROCHLORIDE | 1 mg/7.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 77TI35393C |
| Rxcui | 1250685 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55910-155-55 | Loperamide Hydrochloride | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 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 |
|---|
| 55910-155-55 | 55910015555 | 120 mL in 1 BOTTLE (55910-155-55) | 120 ml | 2026-03-30 | No | No | Current |