Home NDC 46708-071 PANTOPRAZOLE SODIUM
Product NDC 46708-071
11-digit product format 467080071
Labeler code 46708
Product ID 46708-071_02ee7ed6-217f-4128-bbbb-b9390475a65b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pantoprazole sodium injection
Dosage form POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Alembic Pharmaceuticals Limited
Application ANDA219230
Marketing category ANDA
Marketing start 2025-03-31
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 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 A219230-001 PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-03-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219230-001 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 A219230-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-03-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219230-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-03-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219230-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-03-31 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219230-001 PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2025-03-31 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A219230-001 AP 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219230-001 AP 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219230-001 AP 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219230-001 AP 1 a50c72e98297…
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/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 46708-071-01 PANTOPRAZOLE SODIUM 10 mL in 1 VIAL POWDER, FOR SOLUTION 10 1 46708-071-01 PANTOPRAZOLE SODIUM 1 in 1 CARTON POWDER, FOR SOLUTION 1 1 46708-071-10 PANTOPRAZOLE SODIUM 10 mL in 1 VIAL POWDER, FOR SOLUTION 10 1 46708-071-10 PANTOPRAZOLE SODIUM 10 in 1 CARTON POWDER, FOR SOLUTION 10 1 46708-071-25 PANTOPRAZOLE SODIUM 25 in 1 CARTON POWDER, FOR SOLUTION 25 1 46708-071-25 PANTOPRAZOLE SODIUM 10 mL in 1 VIAL POWDER, FOR SOLUTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-071 PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM INJECTION) POWDER, FOR SOLUTION [ALEMBIC PHARMACEUTICALS LIMITED] 1 Current NDC, 6 package rows 20250409_02ee7ed6-217f-4128-bbbb-b9390475a65b.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 46708-071-01 46708007101 1 VIAL in 1 CARTON (46708-071-01) / 10 mL in 1 VIAL 1 vial 2025-03-31 No No Current 46708-071-10 46708007110 10 VIAL in 1 CARTON (46708-071-10) / 10 mL in 1 VIAL 10 vial 2025-03-31 No No Current 46708-071-25 46708007125 25 VIAL in 1 CARTON (46708-071-25) / 10 mL in 1 VIAL 25 vial 2025-03-31 No No Current