Loperamide Hydrochloride
- Product NDC
- 69452-405
- 11-digit product format
- 694520405
- Labeler code
- 69452
- Product ID
- 69452-405_4bd07c07-575e-1543-e063-6294a90a9b3c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride oral
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA220100
- Marketing category
- ANDA
- Marketing start
- 2026-03-02
- 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 |
|---|
| 69452-405-55 | Loperamide Hydrochloride | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 1 |
| 69452-405-93 | Loperamide Hydrochloride | 240 mL in 1 BOTTLE | SOLUTION | 240 | | 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 |
|---|
| 69452-405-55 | 69452040555 | 120 mL in 1 BOTTLE (69452-405-55) | 120 ml | 2026-03-02 | No | No | Current |
| 69452-405-93 | 69452040593 | 240 mL in 1 BOTTLE (69452-405-93) | 240 ml | 2026-03-03 | No | No | Current |
| 69452-405-99 | 69452040599 | 120 mL in 1 BOTTLE (69452-405-99) | 120 ml | 27-FEB-26 | | | Current |