LOPERAMIDE HYDROCHLORIDE
- Product NDC
- 72603-328
- 11-digit product format
- 726030328
- Labeler code
- 72603
- Product ID
- 72603-328_858c2b62-98e6-46d7-9253-9b3a00040a4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LOPERAMIDE HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA218122
- Marketing category
- ANDA
- Marketing start
- 2024-12-01
- 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 |
|---|
| 72603-328-01 | LOPERAMIDE HYDROCHLORIDE | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
| 72603-328-02 | LOPERAMIDE HYDROCHLORIDE | 500 in 1 BOTTLE | CAPSULE | 500 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72603-328 | LOPERAMIDE HYDROCHLORIDE CAPSULE [NORTHSTAR RX LLC] | 1 | Current NDC, 2 package rows | 20241202_858c2b62-98e6-46d7-9253-9b3a00040a4e.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 |
|---|
| 72603-328-01 | 72603032801 | 100 CAPSULE in 1 BOTTLE (72603-328-01) | 100 capsule | 2024-12-01 | No | No | Historical |
| 72603-328-02 | 72603032802 | 500 CAPSULE in 1 BOTTLE (72603-328-02) | 500 capsule | 2024-12-01 | No | No | Historical |