pantoprazole sodium

Generic: pantoprazole sodium

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pantoprazole sodium
Generic Name pantoprazole sodium
Labeler quality care products, llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

pantoprazole sodium 20 mg/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 83008-034
Product ID 83008-034_ac72a3f6-4db4-4ce6-a1ec-8e2fa428448d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202038
Marketing Start 2023-07-18
Marketing End 2027-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83008034
Hyphenated Format 83008-034

Supplemental Identifiers

RxCUI
251872
UNII
6871619Q5X

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 sodium (source: ndc)
Application Number ANDA202038 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (83008-034-30)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (83008-034-60)
source: ndc

Packages (2)

83008-034-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (83008-034-30) 83008-034-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (83008-034-60)

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": "ac72a3f6-4db4-4ce6-a1ec-8e2fa428448d", "openfda": {"unii": ["6871619Q5X"], "rxcui": ["251872"], "spl_set_id": ["a9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e2"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (83008-034-30)", "package_ndc": "83008-034-30", "marketing_end_date": "20270131", "marketing_start_date": "20230718"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (83008-034-60)", "package_ndc": "83008-034-60", "marketing_end_date": "20270331", "marketing_start_date": "20230718"}], "brand_name": "Pantoprazole Sodium", "product_id": "83008-034_ac72a3f6-4db4-4ce6-a1ec-8e2fa428448d", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "83008-034", "generic_name": "Pantoprazole Sodium", "labeler_name": "Quality Care Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pantoprazole Sodium", "active_ingredients": [{"name": "PANTOPRAZOLE SODIUM", "strength": "20 mg/1"}], "application_number": "ANDA202038", "marketing_category": "ANDA", "marketing_end_date": "20270331", "marketing_start_date": "20230718"}