Loperamide Hydrochloride
- Product NDC
- 37012-123
- 11-digit product format
- 370120123
- Labeler code
- 37012
- Product ID
- 37012-123_afec31fa-c850-499e-9f87-475eec5ce0d4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loperamide Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Shopko Stores Operating Co., LLC
- 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 |
|---|
| 37012-123-24 | Loperamide Hydrochloride | 24 in 1 BLISTER PACK | TABLET | 24 | | 1 |
| 37012-123-39 | Loperamide Hydrochloride | 48 in 1 BOTTLE | TABLET | 48 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LOPERAMIDE HYDROCHLORIDE | ACTIVE INGREDIENT | 77TI35393C | LOPERAMIDE HYDROCHLORIDE TABLET [SHOPKO STORES OPERATING CO., LLC] | 1 | |
| LOPERAMIDE | ACTIVE MOIETY | 6X9OC3H4II | LOPERAMIDE HYDROCHLORIDE TABLET [SHOPKO STORES OPERATING CO., LLC] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | LOPERAMIDE HYDROCHLORIDE TABLET [SHOPKO STORES OPERATING CO., LLC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | LOPERAMIDE HYDROCHLORIDE TABLET [SHOPKO STORES OPERATING CO., LLC] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | LOPERAMIDE HYDROCHLORIDE TABLET [SHOPKO STORES OPERATING CO., LLC] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | LOPERAMIDE HYDROCHLORIDE TABLET [SHOPKO STORES OPERATING CO., LLC] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | LOPERAMIDE HYDROCHLORIDE TABLET [SHOPKO STORES OPERATING CO., LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOPERAMIDE HYDROCHLORIDE TABLET [SHOPKO STORES OPERATING CO., LLC] | 1 | |
| POWDERED CELLULOSE | INACTIVE INGREDIENT | SMD1X3XO9M | LOPERAMIDE HYDROCHLORIDE TABLET [SHOPKO STORES OPERATING CO., LLC] | 1 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOPERAMIDE HYDROCHLORIDE TABLET [SHOPKO STORES OPERATING CO., LLC] | 1 | |
| TRISTEARIN | INACTIVE INGREDIENT | P6OCJ2551R | LOPERAMIDE HYDROCHLORIDE TABLET [SHOPKO STORES OPERATING CO., LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 37012-123 | LOPERAMIDE HYDROCHLORIDE TABLET [SHOPKO STORES OPERATING CO., LLC] | 1 | Legacy NDC, 2 package rows | 20130323_47604b25-b0b9-408e-a62b-fa785cca8958.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 37012-123-24 | 37012012324 | 24 in 1 BLISTER PACK | Historical |
| 37012-123-39 | 37012012339 | 48 in 1 BOTTLE | Historical |