Loperamide Hydrochloride
- Product NDC
- 71610-648
- 11-digit product format
- 716100648
- Labeler code
- 71610
- Product ID
- 71610-648_6971060e-f7f3-4055-837d-9c5a16e8ff6d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA215001
- Marketing category
- ANDA
- Marketing start
- 2020-09-25
- 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 | 978006 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-648-53 | Loperamide Hydrochloride | 60 in 1 BOTTLE | CAPSULE | 60 | | 2 |
| 71610-648-60 | Loperamide Hydrochloride | 90 in 1 BOTTLE | CAPSULE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-648 | LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20220512_4d69532c-c71a-4880-9f74-4b37d912cabd.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 |
|---|
| 71610-648-53 | 71610064853 | 60 CAPSULE in 1 BOTTLE (71610-648-53) | 60 capsule | 2022-05-02 | 0000-00-00 | No | No | Current |
| 71610-648-60 | 71610064860 | 90 CAPSULE in 1 BOTTLE (71610-648-60) | 90 capsule | 2022-05-02 | 0000-00-00 | No | No | Current |