lansoprazole

Generic: lansoprazole

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lansoprazole
Generic Name lansoprazole
Labeler macleods pharmaceuticals limited
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

lansoprazole 15 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-310
Product ID 33342-310_75691c2d-2265-4153-bc3a-4f7d5d51e250
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208671
Listing Expiration 2026-12-31
Marketing Start 2024-11-05

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 33342310
Hyphenated Format 33342-310

Supplemental Identifiers

RxCUI
311277 596843
UPC
0333342310071 0333342311078
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 ANDA208671 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-310-07)
source: ndc

Packages (1)

33342-310-07 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-310-07)

Ingredients (1)

lansoprazole (15 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": "75691c2d-2265-4153-bc3a-4f7d5d51e250", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000009724"], "upc": ["0333342310071", "0333342311078"], "unii": ["0K5C5T2QPG"], "rxcui": ["311277", "596843"], "spl_set_id": ["75691c2d-2265-4153-bc3a-4f7d5d51e250"], "pharm_class_pe": ["Inhibition Gastric Acid Secretion [PE]"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-310-07)", "package_ndc": "33342-310-07", "marketing_start_date": "20241105"}], "brand_name": "Lansoprazole", "product_id": "33342-310_75691c2d-2265-4153-bc3a-4f7d5d51e250", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Inhibition Gastric Acid Secretion [PE]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "33342-310", "generic_name": "Lansoprazole", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lansoprazole", "active_ingredients": [{"name": "LANSOPRAZOLE", "strength": "15 mg/1"}], "application_number": "ANDA208671", "marketing_category": "ANDA", "marketing_start_date": "20241105", "listing_expiration_date": "20261231"}