Home NDC 64980-677 PANTOPRAZOLE SODIUM
Product NDC 64980-677
11-digit product format 649800677
Labeler code 64980
Product ID 64980-677_9fe81197-8014-4967-aa15-7525509d532c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PANTOPRAZOLE SODIUM
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA219087
Marketing category ANDA
Marketing start 2025-03-12
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219087-001 PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 20MG BASE TABLET, DELAYED RELEASE / ORAL AB 2025-01-16 A219087-002 PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE TABLET, DELAYED RELEASE / ORAL AB 2025-01-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2026-02-19 14:30 UTC 2026-02 A219087-001 PANTOPRAZOLE SODIUM EQ 20MG BASE TABLET, DELAYED RELEASE / ORAL AB 2025-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219087-002 PANTOPRAZOLE SODIUM EQ 40MG BASE TABLET, DELAYED RELEASE / ORAL AB 2025-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219087-001 PANTOPRAZOLE SODIUM EQ 20MG BASE TABLET, DELAYED RELEASE / ORAL AB 2025-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219087-002 PANTOPRAZOLE SODIUM EQ 40MG BASE TABLET, DELAYED RELEASE / ORAL AB 2025-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219087-001 PANTOPRAZOLE SODIUM EQ 20MG BASE TABLET, DELAYED RELEASE / ORAL AB 2025-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219087-002 PANTOPRAZOLE SODIUM EQ 40MG BASE TABLET, DELAYED RELEASE / ORAL AB 2025-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219087-001 PANTOPRAZOLE SODIUM EQ 20MG BASE TABLET, DELAYED RELEASE / ORAL AB 2025-01-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219087-002 PANTOPRAZOLE SODIUM EQ 40MG BASE TABLET, DELAYED RELEASE / ORAL AB 2025-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219087-001 PANTOPRAZOLE SODIUM EQ 20MG BASE TABLET, DELAYED RELEASE / ORAL AB 2025-01-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219087-002 PANTOPRAZOLE SODIUM EQ 40MG BASE TABLET, DELAYED RELEASE / ORAL AB 2025-01-16 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219087-001 PANTOPRAZOLE SODIUM EQ 20MG BASE TABLET, DELAYED RELEASE / ORAL AB 2025-01-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219087-002 PANTOPRAZOLE SODIUM EQ 40MG BASE TABLET, DELAYED RELEASE / ORAL AB 2025-01-16 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base PANTOPRAZOLE SODIUM
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 251872 Internal RxNorm lookup 314200 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 64980-677-09 PANTOPRAZOLE SODIUM 90 in 1 BOTTLE TABLET, DELAYED RELEASE 90 2 64980-677-10 PANTOPRAZOLE SODIUM 1000 in 1 BOTTLE TABLET, DELAYED RELEASE 1000 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-677 PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [RISING PHARMA HOLDINGS, INC.] 2 Current NDC, 2 package rows 20250515_91a6b13f-457f-4136-9541-c4adb9c3c35c.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 Marketing start Sample Exclude flag Status 64980-677-09 64980067709 90 TABLET, DELAYED RELEASE in 1 BOTTLE (64980-677-09) 2025-03-12 No No Current 64980-677-10 64980067710 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (64980-677-10) 2025-04-21 No No Current