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Loperamide Hydrochloride, Simethicone

NDC 53041-263 · Guardian Drug Company

Generic nameLoperamide Hydrochloride, Simethicone
Dosage formTABLET
RouteORAL
Active ingredient(s)LOPERAMIDE HYDROCHLORIDE, DIMETHICONE
Strength125; 2 mg/1; mg/1
Pharmacologic classOpioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]
Marketing categoryANDA

Packages

53041-263-50 — 1 BLISTER PACK in 1 CARTON (53041-263-50) / 6 TABLET in 1 BLISTER PACK

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

51316-621 — Simethicone Soft Gelatin Capsules, 51316-702 — SIMETHICONE, 51316-904 — Simethicone, 51407-999 — Loperamide Hydrochloride, 51467-100 — Aluminum Hydroxide Dried Gel, Magnesium Hydroxide, and Simethicone, 51655-663 — Loperamide Hydrochloride, 51660-069 — Loperamide HCl and Simethicone, 51660-123 — Loperamide Hydrochloride, 53041-100 — Simethicone, 53041-103 — Simethicone, 53117-248 — Loperamide HCl, 53329-059 — Dimethicone, 53329-060 — Dimethicone, 53329-074 — Dimethicone, 53329-075 — Dimethicone, 53329-078 — Dimethicone, 53329-140 — Dimethicone, 53329-154 — dimethicone, 53329-155 — dimethicone, 53329-157 — Dimethicone, +732 more

Read from: FDA National Drug Code Directory, product.txt and package.txt (accessdata.fda.gov/cder/ndctext.zip) — Snapshot retrieved 2026-08-24, loaded 2026-08-24; CMS Medicare Part B Drug Average Sales Price (ASP) Pricing Files (cms.gov/medicare/payment/part-b-drugs/asp-pricing-files) -- the NDC-HCPCS crosswalk and Part B payment limit files — 2026 Q3 (July 2026 release). All data sources · How to read the labels