dexlansoprazole delayed release

Generic: dexlansoprazole

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexlansoprazole delayed release
Generic Name dexlansoprazole
Labeler a-s medication solutions
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

dexlansoprazole 60 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6514
Product ID 50090-6514_f84a485f-17d9-4fae-90aa-8a4b72fe7d1d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202666
Listing Expiration 2026-12-31
Marketing Start 2022-12-01

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 500906514
Hyphenated Format 50090-6514

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 delayed release (source: ndc)
Generic Name dexlansoprazole (source: ndc)
Application Number ANDA202666 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6514-0)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6514-1)
source: ndc

Packages (2)

50090-6514-0 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6514-0) 50090-6514-1 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6514-1)

Ingredients (1)

dexlansoprazole (60 mg/1)

Linked Drug Pages (1)

Dexlansoprazole delayed release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f84a485f-17d9-4fae-90aa-8a4b72fe7d1d", "openfda": {"nui": ["N0000175525", "N0000000147"], "unii": ["UYE4T5I70X"], "rxcui": ["833213"], "spl_set_id": ["4f44e84f-6219-4445-a67d-df37d18b014d"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6514-0)", "package_ndc": "50090-6514-0", "marketing_start_date": "20230601"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6514-1)", "package_ndc": "50090-6514-1", "marketing_start_date": "20230601"}], "brand_name": "Dexlansoprazole delayed release", "product_id": "50090-6514_f84a485f-17d9-4fae-90aa-8a4b72fe7d1d", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "50090-6514", "generic_name": "dexlansoprazole", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexlansoprazole", "brand_name_suffix": "delayed release", "active_ingredients": [{"name": "DEXLANSOPRAZOLE", "strength": "60 mg/1"}], "application_number": "ANDA202666", "marketing_category": "ANDA", "marketing_start_date": "20221201", "listing_expiration_date": "20261231"}