FDA.reportPublic FDA data

Hyoscyamine Sulfate

Product NDC
69367-678
Requested package NDC
69367-678-01
11-digit product format
693670678
Labeler code
69367
Product ID
69367-678_1c473f01-dccd-4be7-bb0b-9a028f90fd22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-04-02
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
Brand name suffix
SL
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
2b7d1604-3e95-4fc9-a65d-2c06ace16009Available 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
69367-678-01Hyoscyamine SulfateSL100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-678-01EA - Each69367-678baa101e0-613c-4abc-8c0b-a52a87b8520912025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-678HYOSCYAMINE SULFATE SL (HYOSCYAMINE SULFATE) TABLET [WESTMINSTER PHARMACEUTICALS, LLC]2Current NDC, 1 package rows20250423_2b7d1604-3e95-4fc9-a65d-2c06ace16009.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 Sulfate SLHYOSCYAMINE SULFATEWestminster Pharmaceuticals, LLC2b7d1604-3e95-4fc9-a65d-2c06ace160092025-04-21Warnings, Adverse reactionsExact identifier
ndc (package): 69367-678-01
ndc (product): 69367-678
ndc11 (package): 69367067801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletPSN2b7d1604-3e95-4fc9-a65d-2c06ace160093
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletSCD2b7d1604-3e95-4fc9-a65d-2c06ace160093
1046982hyoscyamine sulfate SL 0.125 Disintegrating Sublingual TabletSY2b7d1604-3e95-4fc9-a65d-2c06ace160093

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69367-678-0169367067801100 TABLET in 1 BOTTLE (69367-678-01) 100 tablet2025-04-02NoNoCurrent