Home NDC 77333-831-10 Sodium Bicarbonate
Product NDC 77333-831
Requested package NDC 77333-831-10
11-digit product format 773330831
Labeler code 77333
Product ID 77333-831_eea38435-2c59-7b80-e053-2995a90ab756
Type HUMAN OTC DRUG
Nonproprietary name Sodium Bicarbonate
Dosage form TABLET
Route ORAL
Labeler Gendose Pharmaceuticals, LLC
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2020-05-15
Marketing end 0000-00-00
Substance SODIUM BICARBONATE
Active strength 650 mg/1
Pharmacologic classes Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 77333-831 77333-831-10 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 77333-831-10 Sodium Bicarbonate10 GR. (650 MG) 100 in 1 BOX TABLET 100 3 77333-831-25 Sodium Bicarbonate10 GR. (650 MG) 1 in 1 BLISTER PACK TABLET 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 77333-831 SODIUM BICARBONATE 10 GR. (650 MG) (SODIUM BICARBONATE) TABLET [GENDOSE PHARMACEUTICALS, LLC] 3 Legacy NDC, 2 package rows 20240504_ee90d829-9f1f-52ae-e053-2995a90a29ce.zip
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 77333-831-10 77333083110 100 BLISTER PACK in 1 BOX (77333-831-10) > 1 TABLET in 1 BLISTER PACK (77333-831-25) 100 blister pack 2020-05-15 0000-00-00 No No Current