topcare loperamide hydrochloride is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Loperamide Hydrochloride.
| Product ID | 36800-583_0cfb3ca8-aa2d-40db-8c0f-93b66cebb428 |
| NDC | 36800-583 |
| Product Type | Human Otc Drug |
| Proprietary Name | topcare loperamide hydrochloride |
| Generic Name | Loperamide Hcl |
| Dosage Form | Solution |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-09-12 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA091292 |
| Labeler Name | Topco Associates LLC |
| 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 | 2023-12-31 |
| Marketing Start Date | 2018-09-12 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA091292 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2018-09-12 |
| Ingredient | Strength |
|---|---|
| LOPERAMIDE HYDROCHLORIDE | 1 mg/7.5mL |
| SPL SET ID: | 1cd497b4-d97e-447a-9251-710d2fddbf23 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 36800-583 | topcare loperamide hydrochloride | topcare loperamide hydrochloride |
| 36800-645 | topcare loperamide hydrochloride | topcare loperamide hydrochloride |
| 10202-224 | 7 Select Anti Diarrheal | Loperamide HCl |
| 10202-645 | 7 select anti diarrheal | loperamide HCl |
| 0113-2224 | anti diarrheal | Loperamide HCl |
| 0363-1010 | anti diarrheal | Loperamide HCl |
| 0363-2022 | Anti Diarrheal | loperamide HCl |
| 0363-0375 | Anti-Diarrheal | Loperamide HCl |
| 11822-0375 | Anti-Diarrheal | Loperamide HCl |
| 0498-1071 | Antidiarrheal Relief | Loperamide HCl |
| 0113-1645 | Good Sense antidiarrheal | loperamide HCl |
| 0113-0645 | good sense loperamide hydrochloride | loperamide HCl |
| 0113-6004 | injoy diarrhea relief | Loperamide HCl |
| 0113-7224 | loperamide hydrochloride | Loperamide HCl |
| 0363-0645 | loperamide hydrochloride | loperamide HCl |
| 0363-1645 | loperamide hydrochloride | loperamide HCl |
| 0904-6256 | loperamide hydrochloride | loperamide HCl |
| 0904-6836 | loperamide hydrochloride | loperamide HCl |
| 11822-1645 | loperamide hydrochloride | loperamide HCl |
| 11822-5519 | loperamide hydrochloride | loperamide HCl |
| 11673-900 | Up and Up anti diarrheal | loperamide HCl |