Loperamide Hydrochloride 2mg
- Product NDC
- 25000-001
- 11-digit product format
- 250000001
- Labeler code
- 25000
- Product ID
- 25000-001_2081729a-e6bb-44b8-8295-b7810b77df5e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride Tablets USP, 2mg
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- MARKSANS PHARMA LIMITED
- Application
- ANDA220153
- Marketing category
- ANDA
- Marketing start
- 2025-11-19
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 2 mg/1
- 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 2mg
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LOPERAMIDE HYDROCHLORIDE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 77TI35393C |
| Rxcui | 978010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25000-001-83 | Loperamide Hydrochloride 2mg | 4 in 1 CARTON | TABLET | 4 | | 3 |
| 25000-001-83 | Loperamide Hydrochloride 2mg | 6 in 1 BLISTER PACK | TABLET | 6 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 25000-001-83 | 25000000183 | 4 BLISTER PACK in 1 CARTON (25000-001-83) / 6 TABLET in 1 BLISTER PACK | 4 blister pack | 2025-11-19 | No | No | Current |