Loperamide Hydrochloride
- Product NDC
- 43063-020
- 11-digit product format
- 430630020
- Labeler code
- 43063
- Product ID
- 43063-020_413648bd-6784-dfcf-e063-6294a90a7d88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- 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 |
|---|
| 43063-020-12 | Loperamide Hydrochloride | 12 in 1 BOTTLE, PLASTIC | CAPSULE | 12 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LOPERAMIDE HYDROCHLORIDE | ACTIVE INGREDIENT | 77TI35393C | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| LOPERAMIDE | ACTIVE MOIETY | 6X9OC3H4II | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-020 | LOPERAMIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] | 19 | Current NDC, Legacy NDC, 1 package rows | 20241012_580e6cd4-3f05-4996-9dc3-c50d757ae210.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 |
|---|
| 43063-020-12 | 43063002012 | 12 CAPSULE in 1 BOTTLE, PLASTIC (43063-020-12) | 12 capsule | 2008-10-28 | 0000-00-00 | No | No | Current |