FDA.reportPublic FDA data

Hyoscyamine Sulfate

Product NDC
0615-8554
Requested package NDC
0615-8554-39
11-digit product format
006158554
Labeler code
0615
Product ID
0615-8554_a8b6f497-70e4-4d07-99b6-e5524bd5d141
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-02-15
Substance
HYOSCYAMINE SULFATE
Active strength
.125 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hyoscyamine Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYOSCYAMINE SULFATE.125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F2R8V82B84Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046982Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fdf1f194-2e18-403c-be28-7dd58739ead7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8554-39Hyoscyamine Sulfate30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8554HYOSCYAMINE SULFATE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]1Current NDC, 1 package rows20241116_fdf1f194-2e18-403c-be28-7dd58739ead7.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hyoscyamine SulfateHYOSCYAMINE SULFATENCS HealthCare of KY, LLC dba Vangard Labsfdf1f194-2e18-403c-be28-7dd58739ead72024-11-13Warnings, Adverse reactionsExact identifier
ndc (package): 0615-8554-39
ndc (product): 0615-8554
ndc11 (package): 00615855439

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletPSNfdf1f194-2e18-403c-be28-7dd58739ead71
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletSCDfdf1f194-2e18-403c-be28-7dd58739ead71
1046982hyoscyamine sulfate SL 0.125 Disintegrating Sublingual TabletSYfdf1f194-2e18-403c-be28-7dd58739ead71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0615-8554-390061585543930 TABLET in 1 BLISTER PACK (0615-8554-39) 30 tablet2024-11-07NoNoCurrent