FDA.reportPublic FDA data

Hyoscyamine Sulfate

Product NDC
62559-421
Requested package NDC
62559-421-01
11-digit product format
625590421
Labeler code
62559
Product ID
62559-421_c15f835f-28b6-400f-bcbb-8ccd785381bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET
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
1047905Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cdb8f10a-b426-448f-8991-7724ffa88cb5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-421-01Hyoscyamine Sulfate100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-421-01EA - Each62559-4211cee1f67-2f4b-4e30-aa62-244b63f5adf112024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-421HYOSCYAMINE SULFATE TABLET [ANI PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20240215_cdb8f10a-b426-448f-8991-7724ffa88cb5.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.cdb8f10a-b426-448f-8991-7724ffa88cb52025-09-12Warnings, Adverse reactionsExact identifier
ndc (package): 62559-421-01
ndc (product): 62559-421
ndc11 (package): 62559042101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1047905hyoscyamine sulfate 0.125 MG Oral TabletPSN24dd83d1-ab57-46f9-b5c0-1b1df4de7d103
1047905hyoscyamine sulfate 0.125 MG Oral TabletSCD24dd83d1-ab57-46f9-b5c0-1b1df4de7d103
1047905hyoscyamine sulfate 0.125 MG Oral TabletPSNcdb8f10a-b426-448f-8991-7724ffa88cb52
1047905hyoscyamine sulfate 0.125 MG Oral TabletSCDcdb8f10a-b426-448f-8991-7724ffa88cb52
1047905hyoscyamine sulfate 0.125 MG Oral TabletPSNe291da2e-a693-43f5-8cdd-2b8725371b791
1047905hyoscyamine sulfate 0.125 MG Oral TabletSCDe291da2e-a693-43f5-8cdd-2b8725371b791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62559-421-0162559042101100 TABLET in 1 BOTTLE (62559-421-01) 100 tablet2024-02-15NoNoCurrent