Home NDC 27241-256 Pantoprazole sodium
Product NDC 27241-256
11-digit product format 272410256
Labeler code 27241
Product ID 27241-256_d0fe5d1b-fb0c-4c7b-af8b-cda49f2c8f7e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pantoprazole sodium
Dosage form FOR SUSPENSION
Route ORAL
Labeler Ajanta Pharma USA Inc.
Application ANDA217416
Marketing category ANDA
Marketing start 2023-02-09
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 2027-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217416-001 PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217416-001 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 2026-02-19 14:30 UTC 2026-02 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217416-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-02-09 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Pantoprazole sodium
Listing expiration 2027-12-31 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 27241-256-11 Pantoprazole sodium 1 in 1 PACKET FOR SUSPENSION 1 5 27241-256-38 Pantoprazole sodium 30 in 1 CARTON FOR SUSPENSION 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27241-256 PANTOPRAZOLE SODIUM FOR SUSPENSION [AJANTA PHARMA USA INC.] 4 Current NDC, 2 package rows 20240711_90963a38-f629-45a4-bddd-9e13a55fe0f7.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 · 2 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 27241-256-11 27241025611 1 FOR SUSPENSION in 1 PACKET (27241-256-11) 1 for suspension 2023-02-09 No No Current 27241-256-38 27241025638 30 FOR SUSPENSION in 1 CARTON (27241-256-38) 30 for suspension 2023-02-09 No No Current