loperamide hydrochloride
- Product NDC
- 11822-5519
- 11-digit product format
- 118225519
- Labeler code
- 11822
- Product ID
- 11822-5519_8554615f-b308-40f3-9929-36d437b50992
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- loperamide HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Rite Aid Corporation
- Application
- ANDA091292
- Marketing category
- ANDA
- Marketing start
- 2018-06-18
- 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 |
|---|
| 11822-5519-1 | loperamide hydrochloride | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 5 |
| 11822-5519-2 | loperamide hydrochloride | 240 mL in 1 BOTTLE | SOLUTION | 240 | | 5 |
| 11822-5519-3 | loperamide hydrochloride | 240 mL in 1 BOTTLE | SOLUTION | 240 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11822-5519 | LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SOLUTION [RITE AID CORPORATION] | 5 | Current NDC, Legacy NDC, 3 package rows | 20240717_56334ed4-8cb0-4f5c-9051-6836f0e21337.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 |
|---|
| 11822-5519-1 | 11822551901 | 120 mL in 1 BOTTLE (11822-5519-1) | 120 ml | 2018-06-18 | 0000-00-00 | No | No | Current |
| 11822-5519-2 | 11822551902 | 240 mL in 1 BOTTLE (11822-5519-2) | 240 ml | 2018-06-18 | 0000-00-00 | No | No | Current |
| 11822-5519-3 | 11822551903 | 240 mL in 1 BOTTLE (11822-5519-3) | 240 ml | 2020-03-01 | 0000-00-00 | No | No | Current |