Home NDC 63561-0203-1 Hyoscyamine Sulfate
Product NDC 63561-0203
Requested package NDC 63561-0203-1
11-digit product format 635610203
Labeler code 63561
Product ID 63561-0203_57b12b25-adeb-c9bc-e063-6394a90aa925
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hyoscyamine Sulfate
Dosage form TABLET
Route ORAL
Labeler Granulation Technology, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2026-07-27
Substance HYOSCYAMINE SULFATE
Active strength .125 mg/1
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Hyoscyamine Sulfate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYOSCYAMINE SULFATE .125 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F2R8V82B84 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1047905 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 63561-0203-1 63561020301 100 TABLET in 1 BOTTLE (63561-0203-1) 100 tablet 2026-07-27 0 Current