lansoprazole

Generic: lansoprazole

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

Drug Facts

Product Profile

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

lansoprazole 30 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8621
Product ID 68788-8621_48f527f0-8d17-4696-acd2-e60d0056cce6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203203
Listing Expiration 2026-12-31
Marketing Start 2024-04-04

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 687888621
Hyphenated Format 68788-8621

Supplemental Identifiers

RxCUI
311277
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 ANDA203203 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8621-1)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8621-3)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8621-6)
  • 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8621-8)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8621-9)
source: ndc

Packages (5)

68788-8621-1 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8621-1) 68788-8621-3 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8621-3) 68788-8621-6 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8621-6) 68788-8621-8 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8621-8) 68788-8621-9 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8621-9)

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": "48f527f0-8d17-4696-acd2-e60d0056cce6", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000009724"], "unii": ["0K5C5T2QPG"], "rxcui": ["311277"], "spl_set_id": ["db42468a-450c-4b12-b2f2-e9a76e976d45"], "pharm_class_pe": ["Inhibition Gastric Acid Secretion [PE]"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8621-1)", "package_ndc": "68788-8621-1", "marketing_start_date": "20240405"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8621-3)", "package_ndc": "68788-8621-3", "marketing_start_date": "20240404"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8621-6)", "package_ndc": "68788-8621-6", "marketing_start_date": "20240404"}, {"sample": false, "description": "120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8621-8)", "package_ndc": "68788-8621-8", "marketing_start_date": "20240404"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8621-9)", "package_ndc": "68788-8621-9", "marketing_start_date": "20240404"}], "brand_name": "Lansoprazole", "product_id": "68788-8621_48f527f0-8d17-4696-acd2-e60d0056cce6", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Inhibition Gastric Acid Secretion [PE]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "68788-8621", "generic_name": "Lansoprazole", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lansoprazole", "active_ingredients": [{"name": "LANSOPRAZOLE", "strength": "30 mg/1"}], "application_number": "ANDA203203", "marketing_category": "ANDA", "marketing_start_date": "20240404", "listing_expiration_date": "20261231"}