loperamide hcl and simethicone

Generic: loperamide hcl and simethicone

Labeler: ohm laboratories inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hcl and simethicone
Generic Name loperamide hcl and simethicone
Labeler ohm laboratories inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dimethicone 125 mg/1, loperamide hydrochloride 2 mg/1

Manufacturer
Ohm Laboratories Inc.

Identifiers & Regulatory

Product NDC 51660-069
Product ID 51660-069_86ddd92a-920c-40b8-b0bd-29bfb3b38bfc
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077500
Listing Expiration 2026-12-31
Marketing Start 2022-01-13

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51660069
Hyphenated Format 51660-069

Supplemental Identifiers

RxCUI
978001
UNII
92RU3N3Y1O 77TI35393C
NUI
N0000010282

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name loperamide hcl and simethicone (source: ndc)
Generic Name loperamide hcl and simethicone (source: ndc)
Application Number ANDA077500 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
  • 2 mg/1
source: ndc
Packaging
  • 6 TABLET in 1 BLISTER PACK (51660-069-06)
  • 2 BLISTER PACK in 1 CARTON (51660-069-12) / 6 TABLET in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (51660-069-18) / 6 TABLET in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (51660-069-24) / 6 TABLET in 1 BLISTER PACK
source: ndc

Packages (4)

51660-069-06 6 TABLET in 1 BLISTER PACK (51660-069-06) 51660-069-12 2 BLISTER PACK in 1 CARTON (51660-069-12) / 6 TABLET in 1 BLISTER PACK 51660-069-18 3 BLISTER PACK in 1 CARTON (51660-069-18) / 6 TABLET in 1 BLISTER PACK 51660-069-24 4 BLISTER PACK in 1 CARTON (51660-069-24) / 6 TABLET in 1 BLISTER PACK

Ingredients (2)

dimethicone (125 mg/1) loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

Loperamide HCl and Simethicone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "86ddd92a-920c-40b8-b0bd-29bfb3b38bfc", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O", "77TI35393C"], "rxcui": ["978001"], "spl_set_id": ["06f99f59-e702-49f1-bb1d-e7cf58c54c30"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Ohm Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET in 1 BLISTER PACK (51660-069-06)", "package_ndc": "51660-069-06", "marketing_start_date": "20220113"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (51660-069-12)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "51660-069-12", "marketing_start_date": "20220113"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (51660-069-18)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "51660-069-18", "marketing_start_date": "20220113"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (51660-069-24)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "51660-069-24", "marketing_start_date": "20220113"}], "brand_name": "Loperamide HCl and Simethicone", "product_id": "51660-069_86ddd92a-920c-40b8-b0bd-29bfb3b38bfc", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]", "Skin Barrier Activity [PE]"], "product_ndc": "51660-069", "generic_name": "Loperamide HCl and Simethicone", "labeler_name": "Ohm Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loperamide HCl and Simethicone", "active_ingredients": [{"name": "DIMETHICONE", "strength": "125 mg/1"}, {"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA077500", "marketing_category": "ANDA", "marketing_start_date": "20220113", "listing_expiration_date": "20261231"}