Hyoscyamine Sulfate

Product NDC
62559-424
11-digit product format
625590424
Labeler code
62559
Product ID
62559-424_79ebc4ba-0e48-451b-8eb9-9d1fb64bf25f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
ANI Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-02-15
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
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
62559-424-01Hyoscyamine Sulfate100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-424-01EA - Each62559-424327cb3c9-993b-4ead-b8c0-d2e84b91584712024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-424HYOSCYAMINE SULFATE TABLET [ANI PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20240215_48fa3d71-8c78-4f29-b1f0-ecac8c36473e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletPSN48fa3d71-8c78-4f29-b1f0-ecac8c36473e2
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletSCD48fa3d71-8c78-4f29-b1f0-ecac8c36473e2
1046982hyoscyamine sulfate SL 0.125 Disintegrating Sublingual TabletSY48fa3d71-8c78-4f29-b1f0-ecac8c36473e2
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletPSNfdf1f194-2e18-403c-be28-7dd58739ead71
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletSCDfdf1f194-2e18-403c-be28-7dd58739ead71
1046982hyoscyamine sulfate SL 0.125 Disintegrating Sublingual TabletSYfdf1f194-2e18-403c-be28-7dd58739ead71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62559-424-0162559042401100 TABLET in 1 BOTTLE (62559-424-01) 100 tablet2024-02-15NoNoHistorical