Hyoscyamine Sulfate

Product NDC
69367-679
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 Identifiers#

Field, Values table
FieldValues
UniiF2R8V82B84
Rxcui1046985

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

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) 2025-04-02NoNoHistorical