topcare loperamide hydrochloride
- Product NDC
- 36800-583
- 11-digit product format
- 368000583
- Labeler code
- 36800
- Product ID
- 36800-583_dc29e904-1358-4d41-8eed-d83136200862
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- loperamide HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA091292
- Marketing category
- ANDA
- Marketing start
- 2018-09-12
- 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
- topcare 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 |
|---|
| 36800-583-26 | topcare loperamide hydrochloride | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 5 |
| 36800-583-34 | topcare 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 |
|---|
| 36800-583 | TOPCARE LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SOLUTION [TOPCO ASSOCIATES LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250406_1cd497b4-d97e-447a-9251-710d2fddbf23.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 |
|---|
| 36800-583-26 | 36800058326 | 120 mL in 1 BOTTLE (36800-583-26) | 120 ml | 2018-09-12 | 0000-00-00 | No | No | Current |
| 36800-583-34 | 36800058334 | 240 mL in 1 BOTTLE (36800-583-34) | 240 ml | 2022-09-16 | 0000-00-00 | No | No | Current |