Loperamide Hydrochloride
- Product NDC
- 0615-8497
- 11-digit product format
- 006158497
- Labeler code
- 0615
- Product ID
- 0615-8497_96819325-1225-4982-8e6a-85b217a6b6d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA216876
- Marketing category
- ANDA
- Marketing start
- 2023-01-26
- 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 |
|---|
| 0615-8497-39 | Loperamide Hydrochloride | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8497 | LOPERAMIDE HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 2 | Current NDC, 1 package rows | 20240816_f245e8f4-e06e-492e-8c46-af1fce1633fc.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 |
|---|
| 0615-8497-39 | 00615849739 | 30 CAPSULE in 1 BLISTER PACK (0615-8497-39) | 30 capsule | 2024-01-12 | No | No | Historical |