LOPERAMIDE HYDROCHLORIDE
- Product NDC
- 0904-7472
- 11-digit product format
- 009047472
- Labeler code
- 0904
- Product ID
- 0904-7472_c42d8eae-ae20-496d-b6a5-d58325ecfc7b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LOPERAMIDE HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA218122
- Marketing category
- ANDA
- Marketing start
- 2024-12-20
- 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 |
|---|
| 0904-7472-61 | LOPERAMIDE HYDROCHLORIDE | 100 in 1 CARTON | CAPSULE | 100 | | 2 |
| 0904-7472-61 | LOPERAMIDE HYDROCHLORIDE | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7472 | LOPERAMIDE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS] | 1 | Current NDC, 2 package rows | 20241225_1be585e2-ef49-4210-8a2d-22a326e4cc1b.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 |
|---|
| 0904-7472-61 | 00904747261 | 100 BLISTER PACK in 1 CARTON (0904-7472-61) / 1 CAPSULE in 1 BLISTER PACK | 100 blister pack | 2024-12-20 | No | No | Current |