Loperamide Hydrochloride
- Product NDC
- 63629-8747
- 11-digit product format
- 636298747
- Labeler code
- 63629
- Product ID
- 63629-8747_c7bda4ce-21b5-419f-a6b1-e426edabeff1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA073192
- Marketing category
- ANDA
- Marketing start
- 1993-05-01
- 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 |
|---|
| 63629-8747-1 | Loperamide Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 105 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8747 | LOPERAMIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] | 105 | Current NDC, Legacy NDC, 1 package rows | 20240822_865cf4c7-f643-451b-b0d4-d30bda621f7d.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 |
|---|
| 63629-8747-1 | 63629874701 | 100 CAPSULE in 1 BOTTLE (63629-8747-1) | 100 capsule | 2021-08-20 | 0000-00-00 | No | No | Current |