loperamide hydrochloride
- Product NDC
- 17856-6836
- 11-digit product format
- 178566836
- Labeler code
- 17856
- Product ID
- 17856-6836_34f553fc-3b63-65ee-e063-6294a90a3992
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- loperamide HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Application
- ANDA091292
- Marketing category
- ANDA
- Marketing start
- 2018-11-29
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 17856-6836-1 | loperamide hydrochloride | 72 in 1 BOX, UNIT-DOSE | SOLUTION | 72 | | 4 |
| 17856-6836-2 | loperamide hydrochloride | 50 in 1 BOX, UNIT-DOSE | SOLUTION | 50 | | 4 |
| 17856-6836-3 | loperamide hydrochloride | 7.5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 7.5 | | 4 |
| 17856-6836-4 | loperamide hydrochloride | 15 mL in 1 CUP, UNIT-DOSE | SOLUTION | 15 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17856-6836 | LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SOLUTION [ATLANTIC BIOLOGICALS CORP.] | 4 | Current NDC, Legacy NDC, 4 package rows | 20250514_7030f4ed-3cd1-428e-9cae-3b14933d41f5.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 |
|---|
| 17856-6836-1 | 17856683601 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-6836-1) / 7.5 mL in 1 CUP, UNIT-DOSE (17856-6836-3) | | 2024-04-22 | 0000-00-00 | No | No | Current |
| 17856-6836-2 | 17856683602 | 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-6836-2) / 15 mL in 1 CUP, UNIT-DOSE (17856-6836-4) | | 2024-04-22 | 0000-00-00 | No | No | Current |
| 17856-6836-3 | 17856683603 | 7.5 mL in 1 CUP, UNIT-DOSE | 7.5 ml | | | | | Historical |
| 17856-6836-4 | 17856683604 | 15 mL in 1 CUP, UNIT-DOSE | 15 ml | | | | | Historical |