Home NDC 58602-837 Omeprazole
Product NDC 58602-837
11-digit product format 586020837
Labeler code 58602
Product ID 58602-837_0c2600f3-e9de-4e73-8ee1-9aeb94d228e4
Type HUMAN OTC DRUG
Nonproprietary name Omeprazole
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler Aurohealth LLC
Application ANDA213201
Marketing category ANDA
Marketing start 2023-04-28
Substance OMEPRAZOLE MAGNESIUM
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213201-001 OMEPRAZOLE MAGNESIUM OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28
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 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213201-001 OMEPRAZOLE MAGNESIUM EQ 20MG BASE CAPSULE, DELAYED RELEASE / ORAL 2023-04-28 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Omeprazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OMEPRAZOLE MAGNESIUM 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 426QFE7XLK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198051 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 58602-837-05 Omeprazole 14 in 1 BOTTLE CAPSULE, DELAYED RELEASE 14 2 58602-837-05 Omeprazole 1 in 1 CARTON CAPSULE, DELAYED RELEASE 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58602-837 OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROHEALTH LLC] 2 Current NDC, 2 package rows 20240222_19097902-a5e6-423a-8569-31c569cd3cdb.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 58602-837-05 58602083705 1 BOTTLE in 1 CARTON (58602-837-05) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 1 bottle 2023-04-28 No No Current