dexlansoprazole

Generic: dexlansoprazole

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

Drug Facts

Product Profile

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

dexlansoprazole sesquihydrate 30 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-2085
Product ID 0378-2085_bd08545b-3f1d-44c5-bdd9-05acd7f69a0a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205205
Listing Expiration 2026-12-31
Marketing Start 2024-01-22

Pharmacologic Class

Classes
proton pump inhibitor [epc] proton pump inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03782085
Hyphenated Format 0378-2085

Supplemental Identifiers

RxCUI
833204 833213
UPC
0303782086935 0303782085938
UNII
HS2S9VK3NH

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 ANDA205205 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2085-93)
source: ndc

Packages (1)

0378-2085-93 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2085-93)

Ingredients (1)

dexlansoprazole sesquihydrate (30 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": "bd08545b-3f1d-44c5-bdd9-05acd7f69a0a", "openfda": {"upc": ["0303782086935", "0303782085938"], "unii": ["HS2S9VK3NH"], "rxcui": ["833204", "833213"], "spl_set_id": ["3f9699b5-7614-41cb-bd1d-ff02930e98f3"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2085-93)", "package_ndc": "0378-2085-93", "marketing_start_date": "20240122"}], "brand_name": "Dexlansoprazole", "product_id": "0378-2085_bd08545b-3f1d-44c5-bdd9-05acd7f69a0a", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "0378-2085", "generic_name": "dexlansoprazole", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexlansoprazole", "active_ingredients": [{"name": "DEXLANSOPRAZOLE SESQUIHYDRATE", "strength": "30 mg/1"}], "application_number": "ANDA205205", "marketing_category": "ANDA", "marketing_start_date": "20240122", "listing_expiration_date": "20261231"}