FDA.reportPublic FDA data

Hyoscyamine Sulfate SL

Product NDC
71335-1159
Requested package NDC
71335-1159-0
11-digit product format
713351159
Labeler code
71335
Product ID
71335-1159_7d98a413-c36f-45de-ab25-82533bce72fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hyoscyamine sulfate
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-05-19
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 SL
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046982Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3749da41-19f3-46b2-887d-7f8ae2268700Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1159-0Hyoscyamine Sulfate SL10 in 1 BOTTLETABLET105
71335-1159-1Hyoscyamine Sulfate SL20 in 1 BOTTLETABLET205
71335-1159-2Hyoscyamine Sulfate SL30 in 1 BOTTLETABLET305
71335-1159-3Hyoscyamine Sulfate SL15 in 1 BOTTLETABLET155
71335-1159-4Hyoscyamine Sulfate SL21 in 1 BOTTLETABLET215
71335-1159-5Hyoscyamine Sulfate SL60 in 1 BOTTLETABLET605
71335-1159-6Hyoscyamine Sulfate SL12 in 1 BOTTLETABLET125
71335-1159-7Hyoscyamine Sulfate SL90 in 1 BOTTLETABLET905
71335-1159-8Hyoscyamine Sulfate SL100 in 1 BOTTLETABLET1005
71335-1159-9Hyoscyamine Sulfate SL45 in 1 BOTTLETABLET455

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1159HYOSCYAMINE SULFATE SL (HYOSCYAMINE SULFATE) TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 10 package rows20241116_3749da41-19f3-46b2-887d-7f8ae2268700.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
Hyoscyamine Sulfate SLHYOSCYAMINE SULFATEBryant Ranch Prepack3749da41-19f3-46b2-887d-7f8ae22687002026-06-08Warnings, Adverse reactionsExact identifier
ndc (package): 71335-1159-0
ndc (product): 71335-1159
ndc11 (package): 71335115900

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletPSN3749da41-19f3-46b2-887d-7f8ae22687005
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletSCD3749da41-19f3-46b2-887d-7f8ae22687005
1046982hyoscyamine sulfate SL 0.125 Disintegrating Sublingual TabletSY3749da41-19f3-46b2-887d-7f8ae22687005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-1159-07133511590010 TABLET in 1 BOTTLE (71335-1159-0) 10 tablet2024-10-31NoNoCurrent