Home NDC 70436-190 Esomeprazole sodium
Product NDC 70436-190
11-digit product format 704360190
Labeler code 70436
Product ID 70436-190_ee346f3b-2e1c-7302-e053-2995a90a7157
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Esomeprazole sodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Slate Run Pharmaceuticals, LLC
Application ANDA215732
Marketing category ANDA
Marketing start 2022-02-25
Marketing end 0000-00-00
Substance ESOMEPRAZOLE SODIUM
Active strength 40 mg/5mL
Pharmacologic classes Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 A215732-001 ESOMEPRAZOLE SODIUM ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RS 2022-02-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215732-001 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 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RS 2022-02-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RS 2022-02-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RS 2022-02-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RS 2022-02-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RS 2022-02-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RS 2022-02-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RS 2022-02-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RS 2022-02-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RS 2022-02-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RS 2022-02-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-02-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-02-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-02-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-02-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-02-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-02-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-02-10 4b0b4de00fa7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-02-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-02-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-02-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-02-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-02-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-02-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-02-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-02-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-02-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-02-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-02-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-02-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP 2022-02-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215732-001 ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RS 2022-02-10 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Esomeprazole sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESOMEPRAZOLE SODIUM 40 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L2C9GWQ43H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 486501 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 70436-190-80 Esomeprazole sodium 5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5 3 70436-190-82 Esomeprazole sodium 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70436-190 ESOMEPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SLATE RUN PHARMACEUTICALS, LLC] 3 Legacy NDC, 2 package rows 20231026_23395673-116d-4a8e-b0ce-59f9ca5b3daf.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 Marketing end Sample Exclude flag Status 70436-190-80 70436019080 5 mL in 1 VIAL 5 ml Historical 70436-190-82 70436019082 10 VIAL in 1 CARTON (70436-190-82) > 5 mL in 1 VIAL (70436-190-80) 10 vial 2022-02-25 0000-00-00 No No Current