pantoprazole sodium

Generic: pantoprazole sodium

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pantoprazole sodium
Generic Name pantoprazole sodium
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

pantoprazole sodium 40 mg/10mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-493
Product ID 68083-493_b30bf0cc-9fdd-4e6f-9cb2-4d193651b109
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204400
Listing Expiration 2026-12-31
Marketing Start 2022-05-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083493
Hyphenated Format 68083-493

Supplemental Identifiers

RxCUI
283669
UPC
0368083493011 0368083493257
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 sodium (source: ndc)
Application Number ANDA204400 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/10mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68083-493-01) / 10 mL in 1 VIAL
  • 10 CARTON in 1 PACKAGE (68083-493-10) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL
  • 25 CARTON in 1 PACKAGE (68083-493-25) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL
source: ndc

Packages (3)

68083-493-01 1 VIAL in 1 CARTON (68083-493-01) / 10 mL in 1 VIAL 68083-493-10 10 CARTON in 1 PACKAGE (68083-493-10) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL 68083-493-25 25 CARTON in 1 PACKAGE (68083-493-25) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL

Ingredients (1)

pantoprazole sodium (40 mg/10mL)

Linked Drug Pages (1)

Pantoprazole sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b30bf0cc-9fdd-4e6f-9cb2-4d193651b109", "openfda": {"upc": ["0368083493011", "0368083493257"], "unii": ["6871619Q5X"], "rxcui": ["283669"], "spl_set_id": ["c1ad8f91-3783-4139-8154-e461a53809c1"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-493-01)  / 10 mL in 1 VIAL", "package_ndc": "68083-493-01", "marketing_start_date": "20220518"}, {"sample": false, "description": "10 CARTON in 1 PACKAGE (68083-493-10)  / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL", "package_ndc": "68083-493-10", "marketing_start_date": "20220518"}, {"sample": false, "description": "25 CARTON in 1 PACKAGE (68083-493-25)  / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL", "package_ndc": "68083-493-25", "marketing_start_date": "20220518"}], "brand_name": "Pantoprazole sodium", "product_id": "68083-493_b30bf0cc-9fdd-4e6f-9cb2-4d193651b109", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "68083-493", "generic_name": "Pantoprazole sodium", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pantoprazole sodium", "active_ingredients": [{"name": "PANTOPRAZOLE SODIUM", "strength": "40 mg/10mL"}], "application_number": "ANDA204400", "marketing_category": "ANDA", "marketing_start_date": "20220518", "listing_expiration_date": "20261231"}