loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: edenbridge pharmaceuticals llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hydrochloride
Labeler edenbridge pharmaceuticals llc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
Edenbridge Pharmaceuticals LLC.

Identifiers & Regulatory

Product NDC 42799-605
Product ID 42799-605_462e0177-dc7f-6e57-e063-6394a90a471a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215001
Listing Expiration 2026-12-31
Marketing Start 2020-09-25

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42799605
Hyphenated Format 42799-605

Supplemental Identifiers

RxCUI
978006
UPC
0342799605012 0342799605029
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 ANDA215001 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (42799-605-01)
  • 500 CAPSULE in 1 BOTTLE (42799-605-02)
  • 30 CAPSULE in 1 BOTTLE (42799-605-03)
source: ndc

Packages (3)

42799-605-01 100 CAPSULE in 1 BOTTLE (42799-605-01) 42799-605-02 500 CAPSULE in 1 BOTTLE (42799-605-02) 42799-605-03 30 CAPSULE in 1 BOTTLE (42799-605-03)

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": "462e0177-dc7f-6e57-e063-6394a90a471a", "openfda": {"upc": ["0342799605012", "0342799605029"], "unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["d92819f1-d02d-4959-a019-17d44df6ed2f"], "manufacturer_name": ["Edenbridge Pharmaceuticals LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (42799-605-01)", "package_ndc": "42799-605-01", "marketing_start_date": "20200925"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (42799-605-02)", "package_ndc": "42799-605-02", "marketing_start_date": "20200925"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (42799-605-03)", "package_ndc": "42799-605-03", "marketing_start_date": "20200925"}], "brand_name": "Loperamide Hydrochloride", "product_id": "42799-605_462e0177-dc7f-6e57-e063-6394a90a471a", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "42799-605", "generic_name": "Loperamide Hydrochloride", "labeler_name": "Edenbridge Pharmaceuticals LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Loperamide Hydrochloride", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA215001", "marketing_category": "ANDA", "marketing_start_date": "20200925", "listing_expiration_date": "20261231"}