Home NDC 58354-101-01 NDC 58354-101-01 - Zantanol Tab. This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
Product NDC 58354-101
Requested NDC 58354-101-01
Package NDCs from labels 58354-101-01, 58354-101-02
Manufacturer Cho-A Pharm.Co.,Ltd.
Effective date 2017-02-28
Current FDA listing Not matched in FDA.report NDC product tables FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58354-101-01 Zantanol Tab. 424 mg in 1 CAPSULE TABLET 424 1 58354-101-02 Zantanol Tab. 10 in 1 PACKAGE TABLET 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58354-101 ZANTANOL TAB. (MAGNESIUM OXIDE, MAGNESIUM ALUMINUM HYDRATE) TABLET [CHO-A PHARM.CO.,LTD.] 1 Legacy NDC, 2 package rows 20170301_9b3092fa-86e6-469d-8f73-0626e4c12a28.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 11 of 11 · 220 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sterile Water WATER American Regent, Inc. 78b35864-4bbc-4759-a5c1-7e4f25e22932 2022-01-31 Boxed warning Exact identifier unii: 059QF0KO0R Sterile Diluent for Treprostinil WATER Dr.Reddy's Laboratories Inc., 33050ee2-519b-1f0b-d4df-9e14dd329c57 2021-12-23 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R Ranitidine RANITIDINE Ajanta Pharma USA Inc. fb67e8c7-b817-4253-a1a1-5ecdcee694cf 2021-11-24 Adverse reactions Exact identifier unii: BK76465IHM Sterile Water STERILE WATER B. Braun Medical Inc. d99f9133-e4d0-4dee-b611-dbc3f918b547 2021-08-09 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R Sterile Water WATER B. Braun Medical Inc. 8924e52e-8622-4ed6-a061-1908183e0a18 2021-08-06 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R Eyewash EYEWASH Global Equipment Company c4f78121-4668-2e0c-e053-2995a90ab6c6 2021-06-17 Warnings Exact identifier unii: 059QF0KO0R Sterile Water WATER Asclemed USA, Inc. 45c38269-883c-4198-a9d5-03810a4420ec 2021-01-14 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R Bach Original Flower Remedies WATER Nelson Bach USA Limited 09c76050-42c5-4403-865c-a1f6f668d9c0 2020-06-15 Warnings Exact identifier unii: 059QF0KO0R Sterile Water WATER Baxter Healthcare Company 8bcf5572-49e1-4302-9522-56f57904cb4a 2019-12-29 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R Magnesium Oxide 400mg MAGNESIUM OXIDE 400MG Allegiant Health 2ea68874-8c20-4284-bd0a-f07768057b83 2019-01-28 Warnings Exact identifier unii: 3A3U0GI71G Dynamic Eyewash with Eyecup WATER Dynamic Safety International 7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2 2018-12-17 Warnings Exact identifier unii: 059QF0KO0R Ranitidine Hydrochloride RANITIDINE HYDROCHLORIDE Dr. Reddy's Laboratories Limited 7bf94bf7-fa11-70be-9f65-fe26a3db5a63 2018-11-21 Adverse reactions Exact identifier unii: BK76465IHM Magnesium Oxide MAGNESIUM OXIDE Aphena Pharma Solutions - Tennessee, LLC 11b2ce71-61fd-4e75-a859-a260b1dda080 2018-11-07 Warnings Exact identifier unii: 3A3U0GI71G Magnesium Oxide MAGNESIUM OXIDE Aphena Pharma Solutions - Tennessee, LLC edabc9e4-60ad-407f-97c8-dfec5ee7eeb1 2018-10-25 Warnings Exact identifier unii: 3A3U0GI71G Bio Rock Water ROCK WATER BioActive Nutritional, Inc. 178bd16d-0d4f-49d8-866b-8ab3a3c6889d 2018-07-30 Warnings Exact identifier unii: 059QF0KO0R Sterile Water WATER Baxter Healthcare Corporation ef3e79c5-3f58-4b36-a296-64b7d9a651c1 2017-10-17 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R Eye Wash WATER CVS Pharmacy 049cee29-7ec2-4d5b-8308-f522acde43a7 2017-03-29 Warnings Exact identifier unii: 059QF0KO0R bcdeaf1a-6dcd-4ebe-b50a-b4bc91aa418f 9b3092fa-86e6-469d-8f73-0626e4c12a28 2017-02-28 Warnings Exact identifier spl id: bcdeaf1a-6dcd-4ebe-b50a-b4bc91aa418f spl set id: 9b3092fa-86e6-469d-8f73-0626e4c12a28 Sterile Water WATER Baxter Healthcare Company 210dc9ab-d6ca-4552-ac19-1be17792d290 2016-05-31 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R Acid Reducer RANITIDINE HYDROCHLORIDE WinCo Foods, LLC 70bc7062-ab3c-43eb-b524-0d8c6d1a674d 2014-12-10 Warnings Exact identifier unii: BK76465IHM
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.