dexlansoprazole

Generic: dexlansoprazole

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

Drug Facts

Product Profile

Brand Name dexlansoprazole
Generic Name dexlansoprazole
Labeler remedyrepack inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

dexlansoprazole 60 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3693
Product ID 70518-3693_3b110fbf-7839-f4f8-e063-6394a90aeb7b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202294
Listing Expiration 2026-12-31
Marketing Start 2023-03-28

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 705183693
Hyphenated Format 70518-3693

Supplemental Identifiers

RxCUI
833213
UNII
UYE4T5I70X
NUI
N0000175525 N0000000147

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 dexlansoprazole (source: ndc)
Generic Name dexlansoprazole (source: ndc)
Application Number ANDA202294 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-3693-0)
source: ndc

Packages (1)

70518-3693-0 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-3693-0)

Ingredients (1)

dexlansoprazole (60 mg/1)

Linked Drug Pages (1)

Dexlansoprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3b110fbf-7839-f4f8-e063-6394a90aeb7b", "openfda": {"nui": ["N0000175525", "N0000000147"], "unii": ["UYE4T5I70X"], "rxcui": ["833213"], "spl_set_id": ["40b9b7be-50bd-400e-be49-fc1a1afa693f"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-3693-0)", "package_ndc": "70518-3693-0", "marketing_start_date": "20230328"}], "brand_name": "Dexlansoprazole", "product_id": "70518-3693_3b110fbf-7839-f4f8-e063-6394a90aeb7b", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "70518-3693", "generic_name": "Dexlansoprazole", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexlansoprazole", "active_ingredients": [{"name": "DEXLANSOPRAZOLE", "strength": "60 mg/1"}], "application_number": "ANDA202294", "marketing_category": "ANDA", "marketing_start_date": "20230328", "listing_expiration_date": "20261231"}