Home NDC 33342-306 esomeprazole
Product NDC 33342-306
11-digit product format 333420306
Labeler code 33342
Product ID 33342-306_d68c9247-91c7-4e0f-adc4-2cfa7446580f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name esomeprazole
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA208511
Marketing category ANDA
Marketing start 2024-10-23
Substance ESOMEPRAZOLE
Active strength 20 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 42 .
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 A208511-001 ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS / ORAL 2024-10-23 A208511-002 ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS / ORAL 2024-10-23
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 2026-08-18 06:07:40 2026-07 A208511-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS / ORAL 2024-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208511-002 ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS / ORAL 2024-10-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208511-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS / ORAL 2024-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208511-002 ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS / ORAL 2024-10-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208511-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS / ORAL 2024-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208511-002 ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS / ORAL 2024-10-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208511-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS / ORAL 2024-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208511-002 ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS / ORAL 2024-10-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208511-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208511-002 ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-10-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208511-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208511-002 ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-10-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208511-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208511-002 ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-10-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208511-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-10-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208511-002 ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-10-23 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208511-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-10-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208511-002 ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-10-23 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208511-001 ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED REL PELLETS / ORAL 2024-10-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208511-002 ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE CAPSULE, DELAYED REL PELLETS / ORAL 2024-10-23 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base esomeprazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESOMEPRAZOLE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N3PA6559FT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 606726 Internal RxNorm lookup 606730 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 33342-306-07 esomeprazole 30 in 1 BOTTLE CAPSULE, DELAYED RELEASE 30 1 33342-306-10 esomeprazole 90 in 1 BOTTLE CAPSULE, DELAYED RELEASE 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-306 ESOMEPRAZOLE CAPSULE, DELAYED RELEASE [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 2 package rows 20241201_d68c9247-91c7-4e0f-adc4-2cfa7446580f.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 Marketing start Sample Exclude flag Status 33342-306-07 33342030607 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-306-07) 2024-10-23 No No Current 33342-306-10 33342030610 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-306-10) 2024-10-23 No No Current