Home NDC 54838-506 Hyosyne
Product NDC 54838-506
11-digit product format 548380506
Labeler code 54838
Product ID 54838-506_d9932ae0-7713-4291-9884-7b233cdb2c9f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hyoscyamine Sulfate
Dosage form SOLUTION/ DROPS
Route ORAL
Labeler Lannett Company, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 1997-10-01
Substance HYOSCYAMINE SULFATE
Active strength .125 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Hyosyne
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYOSCYAMINE SULFATE .125 mg/mL
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 1047895 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 54838-506-15 Hyosyne 15 mL in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 15 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Hyoscyamine Sulfate ACTIVE INGREDIENT F2R8V82B84 HYOSYNE (HYOSCYAMINE SULFATE) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 12 Hyoscyamine ACTIVE MOIETY PX44XO846X HYOSYNE (HYOSCYAMINE SULFATE) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 12 alcohol INACTIVE INGREDIENT 3K9958V90M HYOSYNE (HYOSCYAMINE SULFATE) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 12 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL HYOSYNE (HYOSCYAMINE SULFATE) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 12 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA HYOSYNE (HYOSCYAMINE SULFATE) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 12 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 HYOSYNE (HYOSCYAMINE SULFATE) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 12 glycerin INACTIVE INGREDIENT PDC6A3C0OX HYOSYNE (HYOSCYAMINE SULFATE) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 12 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU HYOSYNE (HYOSCYAMINE SULFATE) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 12 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR HYOSYNE (HYOSCYAMINE SULFATE) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 12 sorbitol INACTIVE INGREDIENT 506T60A25R HYOSYNE (HYOSCYAMINE SULFATE) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 12 sucrose INACTIVE INGREDIENT C151H8M554 HYOSYNE (HYOSCYAMINE SULFATE) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 12 water INACTIVE INGREDIENT 059QF0KO0R HYOSYNE (HYOSCYAMINE SULFATE) SOLUTION/ DROPS [SILARX PHARMACEUTICALS, INC] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54838-506 HYOSYNE (HYOSCYAMINE SULFATE) SOLUTION/ DROPS [LANNETT COMPANY, INC.] 18 Current NDC, Legacy NDC, 1 package rows 20240412_38f12473-08e0-4970-a6ef-a825cc7de8d8.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hyosyne HYOSCYAMINE SULFATE Lannett Company, Inc. 38f12473-08e0-4970-a6ef-a825cc7de8d8 2024-04-09 Warnings, Adverse reactions Exact identifier ndc (product): 54838-506
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 54838-506-15 54838050615 15 mL in 1 BOTTLE, PLASTIC (54838-506-15) 15 ml 1997-10-01 0000-00-00 No No Current