loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: mylan institutional inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hydrochloride
Labeler mylan institutional inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
Mylan Institutional Inc.

Identifiers & Regulatory

Product NDC 51079-690
Product ID 51079-690_3a865d0e-9176-11dd-e063-6394a90abcba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072741
Listing Expiration 2026-12-31
Marketing Start 1997-03-10

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51079690
Hyphenated Format 51079-690

Supplemental Identifiers

RxCUI
978006
UNII
77TI35393C

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 (source: ndc)
Generic Name loperamide hydrochloride (source: ndc)
Application Number ANDA072741 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (51079-690-20) / 1 CAPSULE in 1 BLISTER PACK (51079-690-01)
source: ndc

Packages (1)

51079-690-20 100 BLISTER PACK in 1 CARTON (51079-690-20) / 1 CAPSULE in 1 BLISTER PACK (51079-690-01)

Ingredients (1)

loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

Loperamide Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3a865d0e-9176-11dd-e063-6394a90abcba", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["ad71d4ab-d293-47a2-8f3f-2c9f42d76e40"], "manufacturer_name": ["Mylan Institutional Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (51079-690-20)  / 1 CAPSULE in 1 BLISTER PACK (51079-690-01)", "package_ndc": "51079-690-20", "marketing_start_date": "19970310"}], "brand_name": "Loperamide Hydrochloride", "product_id": "51079-690_3a865d0e-9176-11dd-e063-6394a90abcba", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "51079-690", "generic_name": "loperamide hydrochloride", "labeler_name": "Mylan Institutional Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Loperamide Hydrochloride", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA072741", "marketing_category": "ANDA", "marketing_start_date": "19970310", "listing_expiration_date": "20261231"}