FDA.reportPublic FDA data

Levbid

Product NDC
68220-115
Requested package NDC
68220-115-10
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F2R8V82B84Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046770Internal RxNorm lookup
1046771Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
eb13c96f-319a-46f4-9955-ef5fa0a5f110Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevbidHYOSCYAMINE SULFATEViatris Specialty LLCeb13c96f-319a-46f4-9955-ef5fa0a5f1102025-07-15Warnings, Adverse reactionsExact identifier
ndc (package): 68220-115-10
ndc (product): 68220-115
ndc11 (package): 68220011510

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