careone diarrhea control

Generic: loperamide hcl

Labeler: american sales company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name careone diarrhea control
Generic Name loperamide hcl
Labeler american sales company
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
American Sales Company

Identifiers & Regulatory

Product NDC 41520-813
Product ID 41520-813_9781fece-a022-4c74-b5ff-ea39a29b4b16
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075232
Listing Expiration 2026-12-31
Marketing Start 2016-09-14

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 41520813
Hyphenated Format 41520-813

Supplemental Identifiers

RxCUI
978010
UNII
77TI35393C

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 careone diarrhea control (source: ndc)
Generic Name loperamide hcl (source: ndc)
Application Number ANDA075232 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 12 BLISTER PACK in 1 CARTON (41520-813-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 24 BLISTER PACK in 1 CARTON (41520-813-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

41520-813-53 12 BLISTER PACK in 1 CARTON (41520-813-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK 41520-813-62 24 BLISTER PACK in 1 CARTON (41520-813-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

CareOne Diarrhea Control ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9781fece-a022-4c74-b5ff-ea39a29b4b16", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978010"], "spl_set_id": ["17569b2c-38f9-43bd-87ac-eb82b64866e6"], "manufacturer_name": ["American Sales Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (41520-813-53)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "41520-813-53", "marketing_start_date": "20160914"}, {"sample": false, "description": "24 BLISTER PACK in 1 CARTON (41520-813-62)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "41520-813-62", "marketing_start_date": "20160914"}], "brand_name": "CareOne Diarrhea Control", "product_id": "41520-813_9781fece-a022-4c74-b5ff-ea39a29b4b16", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "41520-813", "generic_name": "Loperamide HCl", "labeler_name": "American Sales Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CareOne Diarrhea Control", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA075232", "marketing_category": "ANDA", "marketing_start_date": "20160914", "listing_expiration_date": "20261231"}