dexilant

Generic: dexlansoprazole

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

Drug Facts

Product Profile

Brand Name dexilant
Generic Name dexlansoprazole
Labeler takeda pharmaceuticals america, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

dexlansoprazole 60 mg/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 64764-175
Product ID 64764-175_402fdd3a-6183-4a0d-85ac-61d4221fc921
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022287
Listing Expiration 2026-12-31
Marketing Start 2010-04-12

Pharmacologic Class

Established (EPC)
proton pump inhibitor [epc]
Mechanism of Action
proton pump inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64764175
Hyphenated Format 64764-175

Supplemental Identifiers

RxCUI
833204 833213 902624 902626
UPC
0364764175306 0364764171308
UNII
UYE4T5I70X
NUI
N0000175525 N0000000147

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 dexilant (source: ndc)
Generic Name dexlansoprazole (source: ndc)
Application Number NDA022287 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 7 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-00)
  • 5 BLISTER PACK in 1 TRAY (64764-175-01) / 4 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-02)
  • 10 BLISTER PACK in 1 CARTON (64764-175-11) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-19)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-30)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-90)
source: ndc

Packages (7)

64764-175-00 7 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-00) 64764-175-01 5 BLISTER PACK in 1 TRAY (64764-175-01) / 4 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK 64764-175-02 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-02) 64764-175-11 10 BLISTER PACK in 1 CARTON (64764-175-11) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK 64764-175-19 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-19) 64764-175-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-30) 64764-175-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-90)

Ingredients (1)

dexlansoprazole (60 mg/1)

Linked Drug Pages (1)

Dexilant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "402fdd3a-6183-4a0d-85ac-61d4221fc921", "openfda": {"nui": ["N0000175525", "N0000000147"], "upc": ["0364764175306", "0364764171308"], "unii": ["UYE4T5I70X"], "rxcui": ["833204", "833213", "902624", "902626"], "spl_set_id": ["9819f033-3bbe-442e-8e92-45fec77b237d"], "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": "7 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-00)", "package_ndc": "64764-175-00", "marketing_start_date": "20100412"}, {"sample": false, "description": "5 BLISTER PACK in 1 TRAY (64764-175-01)  / 4 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "64764-175-01", "marketing_start_date": "20100412"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-02)", "package_ndc": "64764-175-02", "marketing_start_date": "20100412"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (64764-175-11)  / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "64764-175-11", "marketing_start_date": "20100412"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-19)", "package_ndc": "64764-175-19", "marketing_start_date": "20100412"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-30)", "package_ndc": "64764-175-30", "marketing_start_date": "20100412"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-175-90)", "package_ndc": "64764-175-90", "marketing_start_date": "20100412"}], "brand_name": "Dexilant", "product_id": "64764-175_402fdd3a-6183-4a0d-85ac-61d4221fc921", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "64764-175", "generic_name": "dexlansoprazole", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexilant", "active_ingredients": [{"name": "DEXLANSOPRAZOLE", "strength": "60 mg/1"}], "application_number": "NDA022287", "marketing_category": "NDA", "marketing_start_date": "20100412", "listing_expiration_date": "20261231"}