prevacid solutab

Generic: lansoprazole

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name prevacid solutab
Generic Name lansoprazole
Labeler takeda pharmaceuticals america, inc.
Dosage Form TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Routes
ORAL
Active Ingredients

lansoprazole 15 mg/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 64764-543
Product ID 64764-543_45f1d5ff-d884-4e40-a16c-313a4e21e32c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021428
Listing Expiration 2026-12-31
Marketing Start 2002-08-30

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 64764543
Hyphenated Format 64764-543

Supplemental Identifiers

RxCUI
206205 206206 311277 351260 351261 866152
UPC
0364764046132
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 prevacid solutab (source: ndc)
Generic Name lansoprazole (source: ndc)
Application Number NDA021428 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 5 BLISTER PACK in 1 TRAY (64764-543-05) / 3 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
  • 10 BLISTER PACK in 1 CARTON (64764-543-11) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (64764-543-30)
source: ndc

Packages (2)

64764-543-05 5 BLISTER PACK in 1 TRAY (64764-543-05) / 3 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK 64764-543-11 10 BLISTER PACK in 1 CARTON (64764-543-11) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (64764-543-30)

Ingredients (1)

lansoprazole (15 mg/1)

Linked Drug Pages (1)

Prevacid, Prevacid SoluTab ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "45f1d5ff-d884-4e40-a16c-313a4e21e32c", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000009724"], "upc": ["0364764046132"], "unii": ["0K5C5T2QPG"], "rxcui": ["206205", "206206", "311277", "351260", "351261", "866152"], "spl_set_id": ["71ba78cb-7e46-43eb-9425-fa130f537f84"], "pharm_class_pe": ["Inhibition Gastric Acid Secretion [PE]"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 BLISTER PACK in 1 TRAY (64764-543-05)  / 3 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "64764-543-05", "marketing_start_date": "20020830"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (64764-543-11)  / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (64764-543-30)", "package_ndc": "64764-543-11", "marketing_start_date": "20020830"}], "brand_name": "Prevacid SoluTab", "product_id": "64764-543_45f1d5ff-d884-4e40-a16c-313a4e21e32c", "dosage_form": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE", "pharm_class": ["Inhibition Gastric Acid Secretion [PE]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "64764-543", "generic_name": "lansoprazole", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prevacid SoluTab", "active_ingredients": [{"name": "LANSOPRAZOLE", "strength": "15 mg/1"}], "application_number": "NDA021428", "marketing_category": "NDA", "marketing_start_date": "20020830", "listing_expiration_date": "20261231"}