LOPERAMIDE HYDROCHLORIDE
- Product NDC
- 68071-3618
- 11-digit product format
- 680713618
- Labeler code
- 68071
- Product ID
- 68071-3618_200c6126-b08d-7aa4-e063-6394a90ab9db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LOPERAMIDE HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA218122
- Marketing category
- ANDA
- Marketing start
- 2023-09-05
- 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 | 978006 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3618-1 | LOPERAMIDE HYDROCHLORIDE | 12 in 1 BOTTLE | CAPSULE | 12 | | 2 |
| 68071-3618-2 | LOPERAMIDE HYDROCHLORIDE | 20 in 1 BOTTLE | CAPSULE | 20 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3618 | LOPERAMIDE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, 2 package rows | 20240820_1adb7a28-9dc6-3f8b-e063-6394a90a9335.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 |
|---|
| 68071-3618-1 | 68071361801 | 12 CAPSULE in 1 BOTTLE (68071-3618-1) | 12 capsule | 2024-06-14 | No | No | Current |
| 68071-3618-2 | 68071361802 | 20 CAPSULE in 1 BOTTLE (68071-3618-2) | 20 capsule | 2024-06-14 | No | No | Current |