Home NDC 69097-531-53 PANTOPRAZOLE SODIUM DELAYED-RELEASE
Product NDC 69097-531
Requested package NDC 69097-531-53
11-digit product format 690970531
Labeler code 69097
Product ID 69097-531_176f3856-e33d-4fb2-9fe9-72d96c5eabe8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pantoprazole sodium granules
Dosage form SUSPENSION
Route ORAL
Labeler Cipla USA Inc.
Application ANDA217458
Marketing category ANDA
Marketing start 2025-04-03
Substance PANTOPRAZOLE SODIUM
Active strength 40 mg/1
Pharmacologic classes Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217458-001 PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-03-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217458-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A217458-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-03-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217458-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-03-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217458-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217458-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217458-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-03-31 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217458-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-03-31 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base PANTOPRAZOLE SODIUM DELAYED-RELEASE
Brand name suffix delayed release
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PANTOPRAZOLE SODIUM 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6871619Q5X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 763306 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69097-531-31 PANTOPRAZOLE SODIUM DELAYED-RELEASEdelayed release 1 in 1 PACKET SUSPENSION 1 4 69097-531-53 PANTOPRAZOLE SODIUM DELAYED-RELEASEdelayed release 30 in 1 CARTON SUSPENSION 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-531 PANTOPRAZOLE SODIUM DELAYED-RELEASE DELAYED RELEASE (PANTOPRAZOLE SODIUM GRANULES) SUSPENSION [CIPLA USA INC.] 4 Current NDC, 2 package rows 20250406_195e06db-b76c-4470-b6a5-a3979c25046d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69097-531-53 69097053153 30 PACKET in 1 CARTON (69097-531-53) / 1 SUSPENSION in 1 PACKET (69097-531-31) 30 packet 2025-04-03 No No Current