Home NDC 42799-952 Pantoprazole Sodium
Product NDC 42799-952
11-digit product format 427990952
Labeler code 42799
Product ID 42799-952_27c1732b-93f7-4c6c-941b-57223d7238ac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pantoprazole Sodium
Dosage form GRANULE, DELAYED RELEASE
Route ORAL
Labeler Edenbridge Pharmaceuticals LLC.
Application ANDA216247
Marketing category ANDA
Marketing start 2023-06-16
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 A216247-001 PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216247-001 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 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 a67488948f0b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216247-001 PANTOPRAZOLE SODIUM EQ 40MG BASE FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2023-06-16 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 42799-952-01 Pantoprazole Sodium 1 in 1 PACKET GRANULE, DELAYED RELEASE 1 4 42799-952-30 Pantoprazole Sodium 30 in 1 CARTON GRANULE, DELAYED RELEASE 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42799-952 PANTOPRAZOLE SODIUM GRANULE, DELAYED RELEASE [EDENBRIDGE PHARMACEUTICALS LLC.] 3 Current NDC, 2 package rows 20230912_a0bb76bc-094a-4d61-9bb2-2226c9da4ae9.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 42799-952-01 42799095201 1 in 1 PACKET Historical 42799-952-30 42799095230 30 PACKET in 1 CARTON (42799-952-30) / 1 GRANULE, DELAYED RELEASE in 1 PACKET (42799-952-01) 30 packet 2023-08-15 No No Current