Loperamide hydrochloride
- Product NDC
- 69842-191
- 11-digit product format
- 698420191
- Labeler code
- 69842
- Product ID
- 69842-191_312fccfe-d465-4e25-9271-7f5d7b4cc6fe
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- loperamide HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- CVS Pharmacy
- Application
- ANDA091292
- Marketing category
- ANDA
- Marketing start
- 2018-06-28
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 1 mg/7.5mL
- 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 | 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 |
|---|
| 69842-191-26 | Loperamide hydrochloride | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 3 |
| 69842-191-34 | Loperamide hydrochloride | 237 mL in 1 BOTTLE | SOLUTION | 237 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69842-191 | LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SOLUTION [CVS PHARMACY] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250416_4c620875-1d8d-4170-be93-8649d9d99f4a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69842-191-26 | 69842019126 | 120 mL in 1 BOTTLE (69842-191-26) | 120 ml | 2018-06-28 | 0000-00-00 | No | No | Current |
| 69842-191-34 | 69842019134 | 237 mL in 1 BOTTLE (69842-191-34) | 237 ml | 2018-06-28 | 0000-00-00 | No | No | Current |