Loperamide Hydrochloride
- Product NDC
- 46122-738
- 11-digit product format
- 461220738
- Labeler code
- 46122
- Product ID
- 46122-738_c627fa26-44ac-4ba9-bc90-454a0ad98871
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amerisource Bergen
- Application
- ANDA206548
- Marketing category
- ANDA
- Marketing start
- 2023-07-05
- 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
- 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 |
|---|
| 46122-738-53 | Loperamide Hydrochloride | 2 in 1 CARTON | TABLET | 2 | | 2 |
| 46122-738-53 | Loperamide Hydrochloride | 6 in 1 BLISTER PACK | TABLET | 6 | | 2 |
| 46122-738-62 | Loperamide Hydrochloride | 6 in 1 BLISTER PACK | TABLET | 6 | | 2 |
| 46122-738-62 | Loperamide Hydrochloride | 4 in 1 CARTON | TABLET | 4 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46122-738 | LOPERAMIDE HYDROCHLORIDE TABLET [AMERISOURCE BERGEN] | 2 | Current NDC, 4 package rows | 20240403_6c15f077-9f90-4262-9c17-a1ac70e45f57.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 46122-738-53 | 46122073853 | 2 BLISTER PACK in 1 CARTON (46122-738-53) / 6 TABLET in 1 BLISTER PACK | 2 blister pack | 2023-07-05 | No | No | Current |
| 46122-738-62 | 46122073862 | 4 BLISTER PACK in 1 CARTON (46122-738-62) / 6 TABLET in 1 BLISTER PACK | 4 blister pack | 2023-07-20 | No | No | Current |