lansoprazole

Generic: lansoprazole

Labeler: medcore llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lansoprazole
Generic Name lansoprazole
Labeler medcore llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

lansoprazole 30 mg/1

Manufacturer
Medcore LLC

Identifiers & Regulatory

Product NDC 82461-713
Product ID 82461-713_1d65f51d-0c4e-4344-8669-691f5223e4c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207394
Listing Expiration 2027-12-31
Marketing Start 2026-01-11

Pharmacologic Class

Established (EPC)
proton pump inhibitor [epc]
Mechanism of Action
proton pump inhibitors [moa]
Physiologic Effect
inhibition gastric acid secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82461713
Hyphenated Format 82461-713

Supplemental Identifiers

RxCUI
311277
UPC
0382461713300
UNII
0K5C5T2QPG
NUI
N0000175525 N0000000147 N0000009724

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 lansoprazole (source: ndc)
Generic Name lansoprazole (source: ndc)
Application Number ANDA207394 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82461-713-30)
source: ndc

Packages (1)

Ingredients (1)

lansoprazole (30 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "1d65f51d-0c4e-4344-8669-691f5223e4c5", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000009724"], "upc": ["0382461713300"], "unii": ["0K5C5T2QPG"], "rxcui": ["311277"], "spl_set_id": ["18b4020f-d7e6-42f8-838d-2b5da152530e"], "pharm_class_pe": ["Inhibition Gastric Acid Secretion [PE]"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]"], "manufacturer_name": ["Medcore LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82461-713-30)", "package_ndc": "82461-713-30", "marketing_start_date": "20260111"}], "brand_name": "Lansoprazole", "product_id": "82461-713_1d65f51d-0c4e-4344-8669-691f5223e4c5", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Inhibition Gastric Acid Secretion [PE]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "82461-713", "generic_name": "Lansoprazole", "labeler_name": "Medcore LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lansoprazole", "active_ingredients": [{"name": "LANSOPRAZOLE", "strength": "30 mg/1"}], "application_number": "ANDA207394", "marketing_category": "ANDA", "marketing_start_date": "20260111", "listing_expiration_date": "20271231"}