dexlansoprazole

Generic: dexlansoprazole

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

Drug Facts

Product Profile

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

dexlansoprazole 60 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-824
Product ID 46708-824_24c33ba6-bf47-434e-903e-f7ced98e030e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219115
Listing Expiration 2026-12-31
Marketing Start 2025-11-14

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 46708824
Hyphenated Format 46708-824

Supplemental Identifiers

RxCUI
833204 833213
UPC
0346708824303 0346708823306
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 ANDA219115 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-824-30)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-824-90)
source: ndc

Packages (2)

46708-824-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-824-30) 46708-824-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-824-90)

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": "24c33ba6-bf47-434e-903e-f7ced98e030e", "openfda": {"nui": ["N0000175525", "N0000000147"], "upc": ["0346708824303", "0346708823306"], "unii": ["UYE4T5I70X"], "rxcui": ["833204", "833213"], "spl_set_id": ["24c33ba6-bf47-434e-903e-f7ced98e030e"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-824-30)", "package_ndc": "46708-824-30", "marketing_start_date": "20251114"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-824-90)", "package_ndc": "46708-824-90", "marketing_start_date": "20251114"}], "brand_name": "Dexlansoprazole", "product_id": "46708-824_24c33ba6-bf47-434e-903e-f7ced98e030e", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "46708-824", "generic_name": "Dexlansoprazole", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexlansoprazole", "active_ingredients": [{"name": "DEXLANSOPRAZOLE", "strength": "60 mg/1"}], "application_number": "ANDA219115", "marketing_category": "ANDA", "marketing_start_date": "20251114", "listing_expiration_date": "20261231"}