anti diarrheal

Generic: loperamide hydrochloride

Labeler: hyvee inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name anti diarrheal
Generic Name loperamide hydrochloride
Labeler hyvee inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
HyVee Inc

Identifiers & Regulatory

Product NDC 42507-224
Product ID 42507-224_be79f54a-1df5-4acc-9f17-ff7d2559d58f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075232
Listing Expiration 2027-12-31
Marketing Start 2003-03-21

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42507224
Hyphenated Format 42507-224

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 anti diarrheal (source: ndc)
Generic Name loperamide hydrochloride (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 (42507-224-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 24 BLISTER PACK in 1 CARTON (42507-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 6 BLISTER PACK in 1 CARTON (42507-224-91) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (3)

Ingredients (1)

loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "be79f54a-1df5-4acc-9f17-ff7d2559d58f", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978010"], "spl_set_id": ["9434cefe-6b13-47c4-b2f7-b8d566c5a4ff"], "manufacturer_name": ["HyVee Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (42507-224-53)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "42507-224-53", "marketing_start_date": "20030321"}, {"sample": false, "description": "24 BLISTER PACK in 1 CARTON (42507-224-62)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "42507-224-62", "marketing_start_date": "20030321"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (42507-224-91)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "42507-224-91", "marketing_start_date": "20030321"}], "brand_name": "anti diarrheal", "product_id": "42507-224_be79f54a-1df5-4acc-9f17-ff7d2559d58f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "42507-224", "generic_name": "Loperamide Hydrochloride", "labeler_name": "HyVee Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "anti diarrheal", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA075232", "marketing_category": "ANDA", "marketing_start_date": "20030321", "listing_expiration_date": "20271231"}