Hyoscyamine Sulfate

Product NDC
69367-678
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 Identifiers#

Field, Values table
FieldValues
UniiF2R8V82B84
Rxcui1046982

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 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

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