FDA.reportPublic FDA data

Hyoscyamine Sulfate

Product NDC
62559-424
Requested package NDC
62559-424-01
11-digit product format
625590424
Labeler code
62559
Product ID
62559-424_79ebc4ba-0e48-451b-8eb9-9d1fb64bf25f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
ANI Pharmaceuticals, Inc.
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
48fa3d71-8c78-4f29-b1f0-ecac8c36473eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-424-01Hyoscyamine Sulfate100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-424-01EA - Each62559-424327cb3c9-993b-4ead-b8c0-d2e84b91584712024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-424HYOSCYAMINE SULFATE TABLET [ANI PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20240215_48fa3d71-8c78-4f29-b1f0-ecac8c36473e.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 SULFATEANI Pharmaceuticals, Inc.48fa3d71-8c78-4f29-b1f0-ecac8c36473e2025-09-12Warnings, Adverse reactionsExact identifier
ndc (package): 62559-424-01
ndc (product): 62559-424
ndc11 (package): 62559042401

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletPSN48fa3d71-8c78-4f29-b1f0-ecac8c36473e2
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletSCD48fa3d71-8c78-4f29-b1f0-ecac8c36473e2
1046982hyoscyamine sulfate SL 0.125 Disintegrating Sublingual TabletSY48fa3d71-8c78-4f29-b1f0-ecac8c36473e2
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
62559-424-0162559042401100 TABLET in 1 BOTTLE (62559-424-01) 100 tablet2024-02-15NoNoCurrent