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NDC 00378-2100-05 Loperamide Hydrochloride 2 mg/1 Details
Loperamide Hydrochloride 2 mg/1
Loperamide Hydrochloride is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is LOPERAMIDE HYDROCHLORIDE.
MedlinePlus Drug Summary
Nonprescription (over-the-counter) loperamide is used to control acute diarrhea (loose stools that come on suddenly and usually lasts less than 2 weeks), including travelers' diarrhea. Prescription loperamide is also used to control acute diarrhea and also ongoing diarrhea associated with inflammatory bowel disease (IBD; condition in which the lining of all or part of the intestine is swollen, irritated, or has sores). Prescription loperamide is also used to reduce the amount of fluid in people with ileostomies (surgery to create an opening for waste to leave the body through the abdomen). Loperamide is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel and by slowing down the movement of the bowel to decrease the number of bowel movements.
Related Packages: 00378-2100-05Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loperamide
Product Information
| NDC | 00378-2100 |
|---|---|
| Product ID | 0378-2100_84c39323-d4c3-452c-b89d-d104dcac4346 |
| Associated GPIs | 47100020100105 |
| GCN Sequence Number | 002842 |
| GCN Sequence Number Description | loperamide HCl CAPSULE 2 MG ORAL |
| HIC3 | D6D |
| HIC3 Description | ANTIDIARRHEALS |
| GCN | 08370 |
| HICL Sequence Number | 001236 |
| HICL Sequence Number Description | LOPERAMIDE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Loperamide Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | loperamide hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 2 |
| Active Ingredient Units | mg/1 |
| Substance Name | LOPERAMIDE HYDROCHLORIDE |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | Opioid Agonist [EPC], Opioid Agonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA072741 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 00378-2100-05 (00378210005)
| NDC Package Code | 0378-2100-05 |
|---|---|
| Billing NDC | 00378210005 |
| Package | 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-2100-05) |
| Marketing Start Date | 1991-09-18 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.23667 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | LOPERAMIDE 2 MG CAPSULE |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |