Loperamide Hydrochloride is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Precision Dose, Inc.. The primary component is Loperamide Hydrochloride.
| Product ID | 68094-129_0001ebe1-983b-4b53-b0d6-57b9feddf00f |
| NDC | 68094-129 |
| Product Type | Human Otc Drug |
| Proprietary Name | Loperamide Hydrochloride |
| Generic Name | Loperamide Hydrochloride |
| Dosage Form | Solution |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-05-18 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA091292 |
| Labeler Name | Precision Dose, Inc. |
| Substance Name | LOPERAMIDE HYDROCHLORIDE |
| Active Ingredient Strength | 1 mg/7.5mL |
| Pharm Classes | Opioid Agonist [EPC], Opioid Agonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2024-12-31 |
| Marketing Start Date | 2020-05-18 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA091292 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2020-05-18 |
| Marketing Category | ANDA |
| Application Number | ANDA091292 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2020-05-18 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-0311 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 0113-7224 | loperamide hydrochloride | Loperamide HCl |
| 0363-0645 | loperamide hydrochloride | loperamide HCl |
| 0363-1645 | loperamide hydrochloride | loperamide HCl |
| 0378-2100 | Loperamide Hydrochloride | loperamide hydrochloride |
| 0615-0362 | Loperamide Hydrochloride | loperamide hydrochloride |
| 0615-8012 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 0615-8087 | Loperamide Hydrochloride | loperamide hydrochloride |
| 0904-6256 | loperamide hydrochloride | loperamide HCl |
| 0904-6836 | loperamide hydrochloride | loperamide HCl |
| 11822-1645 | loperamide hydrochloride | loperamide HCl |
| 11822-5519 | loperamide hydrochloride | loperamide HCl |
| 15127-338 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 17856-0618 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 68016-123 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 68071-4075 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 68094-108 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 68094-107 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 68151-0618 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 68788-9079 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 68788-9704 | loperamide hydrochloride | loperamide hydrochloride |
| 68788-9773 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 68998-123 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 69842-191 | Loperamide hydrochloride | Loperamide hydrochloride |
| 70518-0313 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 70518-0052 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 70518-0072 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 70518-0893 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 76413-314 | Loperamide hydrochloride | Loperamide hydrochloride |
| 21695-692 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 30142-645 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 33261-344 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 35418-123 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 37012-123 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 37808-645 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 41250-645 | loperamide hydrochloride | loperamide hydrochloride |
| 41250-813 | loperamide hydrochloride | loperamide hydrochloride |
| 42708-074 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 43063-431 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 43063-020 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 46122-169 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 50090-0461 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 50090-2859 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 50383-618 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 50436-3974 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 51079-690 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 51660-123 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 51655-547 | Loperamide hydrochloride | Loperamide hydrochloride |
| 53329-664 | Loperamide Hydrochloride | Loperamide Hydrochloride |
| 53808-0707 | Loperamide Hydrochloride | Loperamide Hydrochloride |