Home NDC 0143-9284 Pantoprazole Sodium
Product NDC 0143-9284
11-digit product format 001439284
Labeler code 0143
Product ID 0143-9284_284915b9-082e-4c76-8998-13aff7221045
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pantoprazole Sodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application NDA209463
Marketing category NDA
Marketing start 2017-09-22
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209463-001 PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2017-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N209463-001 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.
Product history page 1 of 2 · 41 observed 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 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2017-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2017-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2017-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2017-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2017-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2017-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2017-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2017-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2017-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2017-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / IV (INFUSION) RLD, RS 2017-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / IV (INFUSION) RLD, RS 2017-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / IV (INFUSION) RLD, RS 2017-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / IV (INFUSION) RLD, RS 2017-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / IV (INFUSION) RLD, RS 2017-06-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / IV (INFUSION) RLD, RS 2017-06-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / IV (INFUSION) 2017-06-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / IV (INFUSION) 2017-06-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209463-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2017-06-30 cb3db0bc1861…
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 · 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 0143-9284-01 Pantoprazole Sodium 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 13 0143-9284-10 Pantoprazole Sodium 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9284 PANTOPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 13 Current NDC, Legacy NDC, 2 package rows 20231031_b02f3f85-8f9b-4d06-8eae-73e592626f3e.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 · 4 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 0143-9284-01 00143928401 1 in 1 VIAL Historical 0143-9284-10 00143928410 10 VIAL in 1 CARTON (0143-9284-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9284-01) 10 vial 2017-09-22 0000-00-00 No No Current