pantoprazole sodium

Generic: pantoprazole

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pantoprazole sodium
Generic Name pantoprazole
Labeler quallent pharmaceuticals health llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

pantoprazole sodium 20 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-010
Product ID 82009-010_48430767-cec0-15e0-e063-6394a90ac032
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202882
Listing Expiration 2027-12-31
Marketing Start 2022-06-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82009010
Hyphenated Format 82009-010

Supplemental Identifiers

RxCUI
251872 314200
UPC
0382009010908 0382009011905
UNII
6871619Q5X

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 pantoprazole sodium (source: ndc)
Generic Name pantoprazole (source: ndc)
Application Number ANDA202882 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (82009-010-90)
source: ndc

Packages (1)

82009-010-90 90 TABLET, DELAYED RELEASE in 1 BOTTLE (82009-010-90)

Ingredients (1)

pantoprazole sodium (20 mg/1)

Linked Drug Pages (1)

PANTOPRAZOLE SODIUM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48430767-cec0-15e0-e063-6394a90ac032", "openfda": {"upc": ["0382009010908", "0382009011905"], "unii": ["6871619Q5X"], "rxcui": ["251872", "314200"], "spl_set_id": ["643eb498-d916-4fb7-9281-32895575ab36"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (82009-010-90)", "package_ndc": "82009-010-90", "marketing_start_date": "20220606"}], "brand_name": "PANTOPRAZOLE SODIUM", "product_id": "82009-010_48430767-cec0-15e0-e063-6394a90ac032", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "82009-010", "generic_name": "PANTOPRAZOLE", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PANTOPRAZOLE SODIUM", "active_ingredients": [{"name": "PANTOPRAZOLE SODIUM", "strength": "20 mg/1"}], "application_number": "ANDA202882", "marketing_category": "ANDA", "marketing_start_date": "20220606", "listing_expiration_date": "20271231"}