Hyoscyamine Sulfate

Product NDC
16477-738
11-digit product format
164770738
Labeler code
16477
Product ID
16477-738_415c6bd6-14f7-8049-e063-6294a90a2f5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Laser Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-01-26
Substance
HYOSCYAMINE SULFATE
Active strength
.375 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYOSCYAMINE SULFATE.375 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF2R8V82B84
Rxcui1046770

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16477-738-01Hyoscyamine Sulfate100 in 1 BOTTLETABLET, EXTENDED RELEASE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16477-738-01EA - Each16477-7386a4c3f7c-b4ca-4129-be5c-79c42f5578b212024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16477-738HYOSCYAMINE SULFATE TABLET, EXTENDED RELEASE [LASER PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20240131_b12f856f-7157-4aee-bf73-1fdcb4834ffc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046770hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral TabletPSNb12f856f-7157-4aee-bf73-1fdcb4834ffc2
104677012 HR hyoscyamine sulfate 0.375 MG Extended Release Oral TabletSCDb12f856f-7157-4aee-bf73-1fdcb4834ffc2
1046770hyoscyamine sulfate 0.375 MG 12 HR Extended Release Oral TabletSYb12f856f-7157-4aee-bf73-1fdcb4834ffc2
1046770hyoscyamine sulfate 375 MCG 12 HR Extended Release Oral TabletSYb12f856f-7157-4aee-bf73-1fdcb4834ffc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
16477-738-0116477073801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16477-738-01) 2024-01-26NoNoHistorical