lansoprazole

Generic: lansoprazole

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

Drug Facts

Product Profile

Brand Name lansoprazole
Generic Name lansoprazole
Labeler nucare pharmaceuticals,inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

lansoprazole 30 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-5119
Product ID 68071-5119_1b546656-8c7f-31ce-e063-6294a90a09dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205868
Listing Expiration 2026-12-31
Marketing Start 2018-06-04

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 680715119
Hyphenated Format 68071-5119

Supplemental Identifiers

RxCUI
311277
UPC
0368071511932
UNII
0K5C5T2QPG
NUI
N0000175525 N0000000147 N0000009724

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 ANDA205868 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-5119-3)
  • 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-5119-4)
source: ndc

Packages (2)

68071-5119-3 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-5119-3) 68071-5119-4 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-5119-4)

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": "1b546656-8c7f-31ce-e063-6294a90a09dd", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000009724"], "upc": ["0368071511932"], "unii": ["0K5C5T2QPG"], "rxcui": ["311277"], "spl_set_id": ["9a277b9e-2e13-27c3-e053-2995a90a7ed5"], "pharm_class_pe": ["Inhibition Gastric Acid Secretion [PE]"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-5119-3)", "package_ndc": "68071-5119-3", "marketing_start_date": "20191220"}, {"sample": false, "description": "14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-5119-4)", "package_ndc": "68071-5119-4", "marketing_start_date": "20191220"}], "brand_name": "Lansoprazole", "product_id": "68071-5119_1b546656-8c7f-31ce-e063-6294a90a09dd", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Inhibition Gastric Acid Secretion [PE]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "68071-5119", "generic_name": "Lansoprazole", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lansoprazole", "active_ingredients": [{"name": "LANSOPRAZOLE", "strength": "30 mg/1"}], "application_number": "ANDA205868", "marketing_category": "ANDA", "marketing_start_date": "20180604", "listing_expiration_date": "20261231"}