FDA.reportPublic FDA data

Levbid

Product NDC
68220-115
11-digit product format
682200115
Labeler code
68220
Product ID
68220-115_bd220cfd-9d8c-4aea-812e-92c0774f1c91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hyoscyamine sulfate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Viatris Specialty LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2008-12-01
Substance
HYOSCYAMINE SULFATE
Active strength
.375 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
Levbid
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF2R8V82B84
Rxcui1046770, 1046771

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68220-115-102024-11-01C16284748780-11030e365-5c31-111a-e063-dadaa90a10e2Levbid ® (hyoscyamine sulfate, 0.375 mg) extended-release tablets Rx Only 201090-01 115 Rev. 07/2025
68220-115-102024-01-30C16284748780-11030e365-5c31-111a-e063-dadaa90a10e2Levbid ® (hyoscyamine sulfate, 0.375 mg) extended-release tablets Rx Only 201090-01 115 Rev. 07/2025

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68220-115-10Levbid1 in 1 BOTTLETABLET, EXTENDED RELEASE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68220-115-10EA - Each68220-1158b062f69-87f0-456a-a89c-377486cd625812015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYOSCYAMINE SULFATEACTIVE INGREDIENTF2R8V82B84LEVBID (HYOSCYAMINE SULFATE) TABLET [ALAVEN PHARMACEUTICAL LLC]1
HYOSCYAMINEACTIVE MOIETYPX44XO846XLEVBID (HYOSCYAMINE SULFATE) TABLET [ALAVEN PHARMACEUTICAL LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68220-115LEVBID (HYOSCYAMINE SULFATE) TABLET, EXTENDED RELEASE [ALAVEN PHARMACEUTICAL LLC]4Current NDC, Legacy NDC, 1 package rows20241103_eb13c96f-319a-46f4-9955-ef5fa0a5f110.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046770hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral TabletPSNeb13c96f-319a-46f4-9955-ef5fa0a5f1106
1046771Levbid 0.375 MG 12HR Extended Release Oral TabletPSNeb13c96f-319a-46f4-9955-ef5fa0a5f1106
104677112 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet [Levbid]SBDeb13c96f-319a-46f4-9955-ef5fa0a5f1106
104677012 HR hyoscyamine sulfate 0.375 MG Extended Release Oral TabletSCDeb13c96f-319a-46f4-9955-ef5fa0a5f1106
104677112 HR Levbid 0.375 MG Extended Release Oral TabletSYeb13c96f-319a-46f4-9955-ef5fa0a5f1106
1046770hyoscyamine sulfate 0.375 MG 12 HR Extended Release Oral TabletSYeb13c96f-319a-46f4-9955-ef5fa0a5f1106
1046770hyoscyamine sulfate 375 MCG 12 HR Extended Release Oral TabletSYeb13c96f-319a-46f4-9955-ef5fa0a5f1106
1046771Levbid (hyoscyamine sulfate 0.375 MG) 12 HR Extended Release Oral TabletSYeb13c96f-319a-46f4-9955-ef5fa0a5f1106
1046771Levbid 0.375 MG 12 HR Extended Release Oral TabletSYeb13c96f-319a-46f4-9955-ef5fa0a5f1106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68220-115-10682200115101 TABLET, EXTENDED RELEASE in 1 BOTTLE (68220-115-10) 2008-12-010000-00-00NoNoCurrent