loperamide hydrochloride

Generic: loperamide hydrochloride

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

Drug Facts

Product Profile

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

loperamide hydrochloride 2 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-2100
Product ID 0378-2100_84c39323-d4c3-452c-b89d-d104dcac4346
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072741
Listing Expiration 2026-12-31
Marketing Start 1991-09-18

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03782100
Hyphenated Format 0378-2100

Supplemental Identifiers

RxCUI
978006
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 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 CAPSULE in 1 BOTTLE, PLASTIC (0378-2100-01)
  • 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-2100-05)
source: ndc

Packages (2)

0378-2100-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2100-01) 0378-2100-05 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-2100-05)

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": "84c39323-d4c3-452c-b89d-d104dcac4346", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["72a7ae47-cdf3-4949-b9f8-f29b153f787f"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2100-01)", "package_ndc": "0378-2100-01", "marketing_start_date": "19910918"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE, PLASTIC (0378-2100-05)", "package_ndc": "0378-2100-05", "marketing_start_date": "19910918"}], "brand_name": "Loperamide Hydrochloride", "product_id": "0378-2100_84c39323-d4c3-452c-b89d-d104dcac4346", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "0378-2100", "generic_name": "loperamide hydrochloride", "labeler_name": "Mylan Pharmaceuticals 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": "19910918", "listing_expiration_date": "20261231"}