FDA.reportPublic FDA data

Hyoscyamine Sulfate

Product NDC
62559-422
Requested package NDC
62559-422-01
11-digit product format
625590422
Labeler code
62559
Product ID
62559-422_e60b7fbe-fdd5-4932-9f26-cecdeb5c60d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
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
1046985Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
66fdfc33-a7b9-465b-84f1-012cdf5517fdAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-422-01Hyoscyamine Sulfate100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-422-01EA - Each62559-4223a17e9f9-c1fd-417d-bbcc-6f8232ab626612024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-422HYOSCYAMINE SULFATE TABLET, ORALLY DISINTEGRATING [ANI PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20240215_66fdfc33-a7b9-465b-84f1-012cdf5517fd.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.66fdfc33-a7b9-465b-84f1-012cdf5517fd2025-09-12Warnings, Adverse reactionsExact identifier
ndc (package): 62559-422-01
ndc (product): 62559-422
ndc11 (package): 62559042201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046985hyoscyamine sulfate 0.125 MG Disintegrating Oral TabletPSN66fdfc33-a7b9-465b-84f1-012cdf5517fd2
1046985hyoscyamine sulfate 0.125 MG Disintegrating Oral TabletSCD66fdfc33-a7b9-465b-84f1-012cdf5517fd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62559-422-0162559042201100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62559-422-01) 2024-02-15NoNoCurrent