loperamide hydrochloride and simethicone

Generic: loperamide hydrochloride and simethicone

Labeler: granules india ltd
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride and simethicone
Generic Name loperamide hydrochloride and simethicone
Labeler granules india ltd
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Granules India Ltd

Identifiers & Regulatory

Product NDC 62207-739
Product ID 62207-739_44e3c6ff-dda8-ee9e-e063-6394a90a03bb
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA215981
Listing Expiration 2026-12-31
Marketing Start 2023-03-01

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62207739
Hyphenated Format 62207-739

Supplemental Identifiers

RxCUI
978001
UPC
0362207739696
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 hydrochloride and simethicone (source: ndc)
Generic Name loperamide hydrochloride and simethicone (source: ndc)
Application Number ANDA215981 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
  • 2 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (62207-739-69) / 6 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

62207-739-69 2 BLISTER PACK in 1 CARTON (62207-739-69) / 6 TABLET in 1 BLISTER PACK

Ingredients (2)

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

Linked Drug Pages (1)

Loperamide Hydrochloride and Simethicone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "44e3c6ff-dda8-ee9e-e063-6394a90a03bb", "openfda": {"nui": ["N0000010282"], "upc": ["0362207739696"], "unii": ["92RU3N3Y1O", "77TI35393C"], "rxcui": ["978001"], "spl_set_id": ["e0c1693e-0e55-4368-a8a5-2f0882fbf952"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Granules India Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (62207-739-69)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "62207-739-69", "marketing_start_date": "20230301"}], "brand_name": "Loperamide Hydrochloride and Simethicone", "product_id": "62207-739_44e3c6ff-dda8-ee9e-e063-6394a90a03bb", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]", "Skin Barrier Activity [PE]"], "product_ndc": "62207-739", "generic_name": "Loperamide Hydrochloride and Simethicone", "labeler_name": "Granules India Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loperamide Hydrochloride and Simethicone", "active_ingredients": [{"name": "DIMETHICONE", "strength": "125 mg/1"}, {"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA215981", "marketing_category": "ANDA", "marketing_start_date": "20230301", "listing_expiration_date": "20261231"}