Home NDC 68083-493 Pantoprazole sodium
Product NDC 68083-493
11-digit product format 680830493
Labeler code 68083
Product ID 68083-493_6cd73b63-72e7-4f03-955d-fa897f905c2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pantoprazole sodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA204400
Marketing category ANDA
Marketing start 2022-05-18
Substance PANTOPRAZOLE SODIUM
Active strength 40 mg/10mL
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 A204400-001 PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204400-001 AP
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 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204400-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-05-18 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/10mL
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 283669 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 68083-493-01 Pantoprazole sodium 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 10 68083-493-01 Pantoprazole sodium 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 10 68083-493-10 Pantoprazole sodium 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 10 68083-493-10 Pantoprazole sodium 10 in 1 PACKAGE INJECTION, POWDER, LYOPHILIZED, 10 10 68083-493-25 Pantoprazole sodium 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 10 68083-493-25 Pantoprazole sodium 25 in 1 PACKAGE INJECTION, POWDER, LYOPHILIZED, 25 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-493 PANTOPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] 9 Current NDC, Legacy NDC, 6 package rows 20250223_c1ad8f91-3783-4139-8154-e461a53809c1.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68083-493-01 68083049301 1 VIAL in 1 CARTON (68083-493-01) / 10 mL in 1 VIAL 1 vial 2022-05-18 0000-00-00 No No Current 68083-493-10 68083049310 10 CARTON in 1 PACKAGE (68083-493-10) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL 10 carton 2022-05-18 0000-00-00 No No Current 68083-493-25 68083049325 25 CARTON in 1 PACKAGE (68083-493-25) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL 25 carton 2022-05-18 0000-00-00 No No Current