Loperamide Hydrochloride
- Product NDC
- 55319-554
- 11-digit product format
- 553190554
- Labeler code
- 55319
- Product ID
- 55319-554_a475a511-e0ef-4fd3-a87a-f9d1fee81086
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Family Dollar Services, Inc.
- Application
- ANDA074091
- Marketing category
- ANDA
- Marketing start
- 1993-02-01
- Marketing end
- 0000-00-00
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 2 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55319-554-53 | Loperamide Hydrochloride | 12 in 1 BLISTER PACK | TABLET | 12 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LOPERAMIDE HYDROCHLORIDE | ACTIVE INGREDIENT | 77TI35393C | LOPERAMIDE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.] | 1 | |
| LOPERAMIDE | ACTIVE MOIETY | 6X9OC3H4II | LOPERAMIDE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | LOPERAMIDE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | LOPERAMIDE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | LOPERAMIDE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | LOPERAMIDE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | LOPERAMIDE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOPERAMIDE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.] | 1 | |
| POWDERED CELLULOSE | INACTIVE INGREDIENT | SMD1X3XO9M | LOPERAMIDE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.] | 1 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOPERAMIDE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.] | 1 | |
| TRISTEARIN | INACTIVE INGREDIENT | P6OCJ2551R | LOPERAMIDE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55319-554 | LOPERAMIDE HYDROCHLORIDE TABLET [FAMILY DOLLAR SERVICES, INC.] | 1 | Legacy NDC, 1 package rows | 20120921_0d94a916-812b-479d-8576-c037db72fa4d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 55319-554-53 | 55319055453 | 12 in 1 BLISTER PACK | Historical |