pantoprazole sodium delayed-release delayed release

Generic: pantoprazole sodium granules

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pantoprazole sodium delayed-release delayed release
Generic Name pantoprazole sodium granules
Labeler cipla usa inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

pantoprazole sodium 40 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-531
Product ID 69097-531_176f3856-e33d-4fb2-9fe9-72d96c5eabe8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217458
Listing Expiration 2026-12-31
Marketing Start 2025-04-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097531
Hyphenated Format 69097-531

Supplemental Identifiers

RxCUI
763306
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 delayed-release delayed release (source: ndc)
Generic Name pantoprazole sodium granules (source: ndc)
Application Number ANDA217458 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (69097-531-53) / 1 SUSPENSION in 1 PACKET (69097-531-31)
source: ndc

Packages (1)

69097-531-53 30 PACKET in 1 CARTON (69097-531-53) / 1 SUSPENSION in 1 PACKET (69097-531-31)

Ingredients (1)

pantoprazole sodium (40 mg/1)

Linked Drug Pages (1)

PANTOPRAZOLE SODIUM DELAYED-RELEASE delayed release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "176f3856-e33d-4fb2-9fe9-72d96c5eabe8", "openfda": {"unii": ["6871619Q5X"], "rxcui": ["763306"], "spl_set_id": ["195e06db-b76c-4470-b6a5-a3979c25046d"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (69097-531-53)  / 1 SUSPENSION in 1 PACKET (69097-531-31)", "package_ndc": "69097-531-53", "marketing_start_date": "20250403"}], "brand_name": "PANTOPRAZOLE SODIUM DELAYED-RELEASE delayed release", "product_id": "69097-531_176f3856-e33d-4fb2-9fe9-72d96c5eabe8", "dosage_form": "SUSPENSION", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "69097-531", "generic_name": "pantoprazole sodium granules", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PANTOPRAZOLE SODIUM DELAYED-RELEASE", "brand_name_suffix": "delayed release", "active_ingredients": [{"name": "PANTOPRAZOLE SODIUM", "strength": "40 mg/1"}], "application_number": "ANDA217458", "marketing_category": "ANDA", "marketing_start_date": "20250403", "listing_expiration_date": "20261231"}