FDA.reportPublic FDA data

Hyoscyamine Sulfate

Product NDC
63561-0197
11-digit product format
635610197
Labeler code
63561
Product ID
63561-0197_4f86347a-9346-8ff6-e063-6294a90a59c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Granulation Technology, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-04-16
Substance
HYOSCYAMINE SULFATE
Active strength
.125 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hyoscyamine Sulfate
Listing expiration
2027-12-31

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
4f863ae9-d010-b2f5-e063-6394a90a1a95Available 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
63561-0197-1Hyoscyamine Sulfate100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1001

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 SULFATEGranulation Technology, Inc.4f863ae9-d010-b2f5-e063-6394a90a1a952026-04-15Warnings, Adverse reactionsExact identifier
ndc (product): 63561-0197

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046985hyoscyamine sulfate 0.125 MG Disintegrating Oral TabletPSN51a07955-485f-1357-e063-6394a90ad3f82
1046985hyoscyamine sulfate 0.125 MG Disintegrating Oral TabletSCD51a07955-485f-1357-e063-6394a90ad3f82
1046985hyoscyamine sulfate 0.125 MG Disintegrating Oral TabletPSN4f863ae9-d010-b2f5-e063-6394a90a1a951
1046985hyoscyamine sulfate 0.125 MG Disintegrating Oral TabletSCD4f863ae9-d010-b2f5-e063-6394a90a1a951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63561-0197-163561019701100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63561-0197-1) 2026-04-16NoNoCurrent