FDA.reportPublic FDA data

Levsin

Product NDC
68220-112
Requested package NDC
68220-112-10
11-digit product format
682200112
Labeler code
68220
Product ID
68220-112_b443f3e7-e3b1-4471-b924-a0c038b58d02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hyoscyamine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Viatris Specialty LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1955-06-01
Substance
HYOSCYAMINE SULFATE
Active strength
.125 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
Levsin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYOSCYAMINE SULFATE.125 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
1047905Internal RxNorm lookup
1047907Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
32388e18-08de-455c-aad4-9c2264435f0fAvailable on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68220-112-102024-11-0132388e18-08de-455c-aad4-9c2264435f0f
68220-112-502024-11-0132388e18-08de-455c-aad4-9c2264435f0f
68220-112-102024-01-3032388e18-08de-455c-aad4-9c2264435f0f
68220-112-502024-01-3032388e18-08de-455c-aad4-9c2264435f0f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68220-112-10Levsin100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68220-112-10EA - Each68220-112929fb6ff-9ec3-454e-b02d-354d8fbd2a3712013-06-04
68220-112-50EA - Each68220-112a814cb19-6223-4dd5-a1e1-17261b5532a112013-06-04

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68220-112LEVSIN (HYOSCYAMINE SULFATE) TABLET [ALAVEN PHARMACEUTICAL LLC]4Current NDC, Legacy NDC, 1 package rows20241103_32388e18-08de-455c-aad4-9c2264435f0f.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
LevsinHYOSCYAMINE SULFATEViatris Specialty LLC32388e18-08de-455c-aad4-9c2264435f0f2025-07-15Warnings, Adverse reactionsExact identifier
ndc (package): 68220-112-10
ndc (product): 68220-112
ndc11 (package): 68220011210

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1047905hyoscyamine sulfate 0.125 MG Oral TabletPSN32388e18-08de-455c-aad4-9c2264435f0f6
1047907Levsin 0.125 MG Oral TabletPSN32388e18-08de-455c-aad4-9c2264435f0f6
1047907hyoscyamine sulfate 0.125 MG Oral Tablet [Levsin]SBD32388e18-08de-455c-aad4-9c2264435f0f6
1047905hyoscyamine sulfate 0.125 MG Oral TabletSCD32388e18-08de-455c-aad4-9c2264435f0f6
1047907Levsin 0.125 MG Oral TabletSY32388e18-08de-455c-aad4-9c2264435f0f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68220-112-1068220011210100 TABLET in 1 BOTTLE (68220-112-10) 100 tablet1955-06-010000-00-00NoNoCurrent