Home NDC 69097-507 Esomeprazole magnesium
Product NDC 69097-507
11-digit product format 690970507
Labeler code 69097
Product ID 69097-507_75c5150c-7eab-4f85-9c34-80c0ecb4a07b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Esomeprazole magnesium
Dosage form FOR SUSPENSION
Route ORAL
Labeler Cipla USA Inc.
Application ANDA217714
Marketing category ANDA
Marketing start 2025-01-07
Substance ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Active strength 2.5 mg/1
Pharmacologic classes Cytochrome P450 2C19 Inhibitors [MoA], 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217714-001 ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 2.5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-01-07 A217714-002 ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-01-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A217714-001 ESOMEPRAZOLE MAGNESIUM EQ 2.5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217714-002 ESOMEPRAZOLE MAGNESIUM EQ 5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217714-001 ESOMEPRAZOLE MAGNESIUM EQ 2.5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-01-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217714-002 ESOMEPRAZOLE MAGNESIUM EQ 5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-01-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217714-001 ESOMEPRAZOLE MAGNESIUM EQ 2.5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-01-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217714-002 ESOMEPRAZOLE MAGNESIUM EQ 5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-01-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217714-001 ESOMEPRAZOLE MAGNESIUM EQ 2.5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-01-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217714-002 ESOMEPRAZOLE MAGNESIUM EQ 5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-01-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217714-001 ESOMEPRAZOLE MAGNESIUM EQ 2.5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-01-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217714-002 ESOMEPRAZOLE MAGNESIUM EQ 5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-01-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217714-001 ESOMEPRAZOLE MAGNESIUM EQ 2.5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-01-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217714-002 ESOMEPRAZOLE MAGNESIUM EQ 5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-01-07 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217714-001 ESOMEPRAZOLE MAGNESIUM EQ 2.5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-01-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217714-002 ESOMEPRAZOLE MAGNESIUM EQ 5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE / ORAL AB 2025-01-07 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Esomeprazole magnesium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESOMEPRAZOLE MAGNESIUM DIHYDRATE 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 36H71644EQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1297658 Internal RxNorm lookup 1297761 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 69097-507-31 Esomeprazole magnesium 30 in 1 CARTON FOR SUSPENSION 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-507 ESOMEPRAZOLE MAGNESIUM FOR SUSPENSION [CIPLA USA INC.] 6 Current NDC, 1 package rows 20250108_e89589f1-945e-429a-819e-61755cba77fa.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 69097-507-31 69097050731 30 FOR SUSPENSION in 1 CARTON (69097-507-31) 30 for suspension 2025-01-07 No No Current