FDA.reportPublic FDA data

Hyoscyamine Sulfate

Product NDC
62559-423
11-digit product format
625590423
Labeler code
62559
Product ID
62559-423_1f3b6482-bdac-411a-8eee-561674ac224e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-02-15
Substance
HYOSCYAMINE SULFATE
Active strength
.375 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.375 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
1046770Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3859133e-88bd-4dd5-90a0-82b64347f1dbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-423-01Hyoscyamine Sulfate100 in 1 BOTTLETABLET, EXTENDED RELEASE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-423-01EA - Each62559-4237bc03ee1-f1ec-4a33-9b0e-d823c06260cc12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-423HYOSCYAMINE SULFATE TABLET, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20240215_3859133e-88bd-4dd5-90a0-82b64347f1db.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.3859133e-88bd-4dd5-90a0-82b64347f1db2025-09-12Warnings, Adverse reactionsExact identifier
ndc (product): 62559-423

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046770hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral TabletPSN3859133e-88bd-4dd5-90a0-82b64347f1db2
104677012 HR hyoscyamine sulfate 0.375 MG Extended Release Oral TabletSCD3859133e-88bd-4dd5-90a0-82b64347f1db2
1046770hyoscyamine sulfate 0.375 MG 12 HR Extended Release Oral TabletSY3859133e-88bd-4dd5-90a0-82b64347f1db2
1046770hyoscyamine sulfate 375 MCG 12 HR Extended Release Oral TabletSY3859133e-88bd-4dd5-90a0-82b64347f1db2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62559-423-0162559042301100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62559-423-01) 2024-02-15NoNoCurrent