anti diarrheal

Generic: loperamide hcl

Labeler: h e b
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name anti diarrheal
Generic Name loperamide hcl
Labeler h e b
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

loperamide hydrochloride 1 mg/7.5mL

Manufacturer
H E B

Identifiers & Regulatory

Product NDC 37808-449
Product ID 37808-449_80acab10-ff9e-4353-8bf0-a9ea6138e047
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA091292
Listing Expiration 2026-12-31
Marketing Start 2018-06-22

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 37808449
Hyphenated Format 37808-449

Supplemental Identifiers

RxCUI
1250685
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 hcl (source: ndc)
Application Number ANDA091292 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/7.5mL
source: ndc
Packaging
  • 240 mL in 1 BOTTLE (37808-449-34)
source: ndc

Packages (1)

37808-449-34 240 mL in 1 BOTTLE (37808-449-34)

Ingredients (1)

loperamide hydrochloride (1 mg/7.5mL)

Linked Drug Pages (1)

anti diarrheal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "80acab10-ff9e-4353-8bf0-a9ea6138e047", "openfda": {"unii": ["77TI35393C"], "rxcui": ["1250685"], "spl_set_id": ["01964f8a-f05c-4f72-9530-e0cffd981ffa"], "manufacturer_name": ["H E B"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "240 mL in 1 BOTTLE (37808-449-34)", "package_ndc": "37808-449-34", "marketing_start_date": "20180622"}], "brand_name": "anti diarrheal", "product_id": "37808-449_80acab10-ff9e-4353-8bf0-a9ea6138e047", "dosage_form": "SOLUTION", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "37808-449", "generic_name": "loperamide HCl", "labeler_name": "H E B", "product_type": "HUMAN OTC DRUG", "brand_name_base": "anti diarrheal", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "1 mg/7.5mL"}], "application_number": "ANDA091292", "marketing_category": "ANDA", "marketing_start_date": "20180622", "listing_expiration_date": "20261231"}