Home NDC 47781-012-01 Hyoscyamine Sulfate
Product NDC 47781-012
Requested package NDC 47781-012-01
11-digit product format 477810012
Labeler code 47781
Product ID 47781-012_c2234762-0581-ad1c-62ca-9323e93b1c16
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hyoscyamine Sulfate
Dosage form TABLET, ORALLY DISINTEGRATING
Route ORAL
Labeler Alvogen Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2022-03-07
Marketing end 0000-00-00
Substance HYOSCYAMINE SULFATE
Active strength 0 mg/1
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 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 47781-012 47781-012-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47781-012 HYOSCYAMINE SULFATE TABLET, ORALLY DISINTEGRATING [ALVOGEN INC.] 3 Legacy NDC 20240509_7cd2c973-d066-4948-494f-bda7b80e5b14.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 47781-012-01 47781001201 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (47781-012-01) 2022-03-07 0000-00-00 No No Current