dexlansoprazole

Generic: dexlansoprazole

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

dexlansoprazole 60 mg/1

Manufacturer
ENDO USA, Inc.

Identifiers & Regulatory

Product NDC 49884-148
Product ID 49884-148_91737170-78eb-4113-9d46-f93742b7c498
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202294
Listing Expiration 2026-12-31
Marketing Start 2022-11-22

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 49884148
Hyphenated Format 49884-148

Supplemental Identifiers

RxCUI
833204 833213
UPC
0349884147112 0349884148096
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 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
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-148-09)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-148-11)
source: ndc

Packages (2)

49884-148-09 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-148-09) 49884-148-11 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-148-11)

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": "91737170-78eb-4113-9d46-f93742b7c498", "openfda": {"nui": ["N0000175525", "N0000000147"], "upc": ["0349884147112", "0349884148096"], "unii": ["UYE4T5I70X"], "rxcui": ["833204", "833213"], "spl_set_id": ["d7452a26-db20-42fc-868a-a3e3606ca895"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]"], "manufacturer_name": ["ENDO USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-148-09)", "package_ndc": "49884-148-09", "marketing_start_date": "20221122"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-148-11)", "package_ndc": "49884-148-11", "marketing_start_date": "20221122"}], "brand_name": "Dexlansoprazole", "product_id": "49884-148_91737170-78eb-4113-9d46-f93742b7c498", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "49884-148", "generic_name": "Dexlansoprazole", "labeler_name": "ENDO USA, 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": "20221122", "listing_expiration_date": "20261231"}