lansoprazole

Generic: lansoprazole

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

lansoprazole 30 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-039
Product ID 82009-039_2f333840-e837-3207-e063-6294a90aea03
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203083
Listing Expiration 2026-12-31
Marketing Start 2022-10-14

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 82009039
Hyphenated Format 82009-039

Supplemental Identifiers

RxCUI
311277
UPC
0382009039053
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 ANDA203083 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-039-05)
source: ndc

Packages (1)

82009-039-05 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-039-05)

Ingredients (1)

lansoprazole (30 mg/1)

Linked Drug Pages (1)

Lansoprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2f333840-e837-3207-e063-6294a90aea03", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000009724"], "upc": ["0382009039053"], "unii": ["0K5C5T2QPG"], "rxcui": ["311277"], "spl_set_id": ["cc006372-32d3-4539-921a-6bc9ec496b28"], "pharm_class_pe": ["Inhibition Gastric Acid Secretion [PE]"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-039-05)", "package_ndc": "82009-039-05", "marketing_start_date": "20221014"}], "brand_name": "Lansoprazole", "product_id": "82009-039_2f333840-e837-3207-e063-6294a90aea03", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Inhibition Gastric Acid Secretion [PE]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "82009-039", "generic_name": "Lansoprazole", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lansoprazole", "active_ingredients": [{"name": "LANSOPRAZOLE", "strength": "30 mg/1"}], "application_number": "ANDA203083", "marketing_category": "ANDA", "marketing_start_date": "20221014", "listing_expiration_date": "20261231"}