Loperamide Hydrochloride
- Product NDC
- 67544-700
- 11-digit product format
- 675440700
- Labeler code
- 67544
- Product ID
- 67544-700_c2706f50-da69-4714-9401-fa9c096a1824
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- loperamide hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA072741
- Marketing category
- ANDA
- Marketing start
- 2012-10-12
- Marketing end
- 0000-00-00
- Substance
- LOPERAMIDE HYDROCHLORIDE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|
| 67544-700-53 | Loperamide Hydrochloride | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | | 2 |
| 67544-700-60 | Loperamide Hydrochloride | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LOPERAMIDE HYDROCHLORIDE | ACTIVE INGREDIENT | 77TI35393C | LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| LOPERAMIDE | ACTIVE MOIETY | 6X9OC3H4II | LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67544-700 | LOPERAMIDE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Legacy NDC, 2 package rows | 20191227_6deb0658-c96e-40bd-b3a3-9655a4769270.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 |
|---|
| 67544-700-53 | 67544070053 | 60 CAPSULE in 1 BOTTLE, PLASTIC (67544-700-53) | 60 capsule | 2012-10-15 | 0000-00-00 | No | No | Current |
| 67544-700-60 | 67544070060 | 90 CAPSULE in 1 BOTTLE, PLASTIC (67544-700-60) | 90 capsule | 2012-10-15 | 0000-00-00 | No | No | Current |