FDA.reportPublic FDA data

Levsin

Product NDC
68220-113
11-digit product format
682200113
Labeler code
68220
Product ID
68220-113_18c4b7b1-8d9a-46c2-aa14-37820d5d6496
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hyoscyamine sulfate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Viatris Specialty LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2008-12-01
Substance
HYOSCYAMINE SULFATE
Active strength
.125 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levsin
Brand name suffix
SL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYOSCYAMINE SULFATE.125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF2R8V82B84
Rxcui1046982, 1047908

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68220-113-102024-11-01C16284748780-11030e365-33d0-111a-e063-dadaa90a10e2Levsin ® /SL tablets (hyoscyamine sulfate tablets USP) Rx Only 201092-01 Rev. 07/2025
68220-113-502024-11-01C16284748780-11030e365-33d0-111a-e063-dadaa90a10e2Levsin ® /SL tablets (hyoscyamine sulfate tablets USP) Rx Only 201092-01 Rev. 07/2025
68220-113-102024-01-30C16284748780-11030e365-33d0-111a-e063-dadaa90a10e2Levsin ® /SL tablets (hyoscyamine sulfate tablets USP) Rx Only 201092-01 Rev. 07/2025
68220-113-502024-01-30C16284748780-11030e365-33d0-111a-e063-dadaa90a10e2Levsin ® /SL tablets (hyoscyamine sulfate tablets USP) Rx Only 201092-01 Rev. 07/2025

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68220-113-10LevsinSL100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68220-113-10EA - Each68220-11331042fe5-c0f8-41d0-8d8f-127237cecd0f12013-06-04
68220-113-50EA - Each68220-1137ae0fdaf-0379-4c52-a788-40fa59cb508a12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYOSCYAMINE SULFATEACTIVE INGREDIENTF2R8V82B84LEVSIN SL (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [ALAVEN PHARMACEUTICAL LLC]1
HYOSCYAMINEACTIVE MOIETYPX44XO846XLEVSIN SL (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [ALAVEN PHARMACEUTICAL LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68220-113LEVSIN SL (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [ALAVEN PHARMACEUTICAL LLC]4Current NDC, Legacy NDC, 1 package rows20241103_f38ece41-b890-11e2-9e96-0800200c9a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletPSNf38ece41-b890-11e2-9e96-0800200c9a666
1047908Levsin SL 0.125 MG Sublingual TabletPSNf38ece41-b890-11e2-9e96-0800200c9a666
1047908hyoscyamine sulfate 0.125 MG Sublingual Tablet [Levsin]SBDf38ece41-b890-11e2-9e96-0800200c9a666
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletSCDf38ece41-b890-11e2-9e96-0800200c9a666
1046982hyoscyamine sulfate SL 0.125 Disintegrating Sublingual TabletSYf38ece41-b890-11e2-9e96-0800200c9a666
1047908Levsin 0.125 MG Sublingual TabletSYf38ece41-b890-11e2-9e96-0800200c9a666

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68220-113-1068220011310100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68220-113-10) 2008-12-010000-00-00NoNoCurrent
68220-113-5068220011350500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68220-113-50) 2008-12-010000-00-00NoNoCurrent