FDA.reportPublic FDA data

Hyoscyamine Sulfate

Product NDC
69367-679
Requested package NDC
69367-679-01
11-digit product format
693670679
Labeler code
69367
Product ID
69367-679_d40f28c0-8358-4b25-a957-568e01125dfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET, ORALLY DISINTEGRATING
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
ODT
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
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
9429898d-301f-4ebc-8b1d-60595f76f1e3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-679-01Hyoscyamine SulfateODT100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-679-01EA - Each69367-6798ec898a6-703e-456b-8d0f-f56fb6da8ef812025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-679HYOSCYAMINE SULFATE ODT (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [WESTMINSTER PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20250417_9429898d-301f-4ebc-8b1d-60595f76f1e3.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 ODTHYOSCYAMINE SULFATEWestminster Pharmaceuticals, LLC9429898d-301f-4ebc-8b1d-60595f76f1e32025-04-09Warnings, Adverse reactionsExact identifier
ndc (package): 69367-679-01
ndc (product): 69367-679
ndc11 (package): 69367067901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046985hyoscyamine sulfate 0.125 MG Disintegrating Oral TabletPSN9429898d-301f-4ebc-8b1d-60595f76f1e32
1046985hyoscyamine sulfate 0.125 MG Disintegrating Oral TabletSCD9429898d-301f-4ebc-8b1d-60595f76f1e32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69367-679-0169367067901100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (69367-679-01) 2025-04-02NoNoCurrent