FDA.reportPublic FDA data

Hyoscyamine Sulfate

Product NDC
71335-1647
Requested package NDC
71335-1647-7
11-digit product format
713351647
Labeler code
71335
Product ID
71335-1647_93e2804c-b4e4-47e5-a379-819b8dce958c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-10-01
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
Listing expiration
2026-12-31

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
57b26b7f-f22d-4ffb-a748-d430572f92a7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1647-0Hyoscyamine Sulfate10 in 1 BOTTLETABLET103
71335-1647-1Hyoscyamine Sulfate20 in 1 BOTTLETABLET203
71335-1647-2Hyoscyamine Sulfate30 in 1 BOTTLETABLET303
71335-1647-3Hyoscyamine Sulfate15 in 1 BOTTLETABLET153
71335-1647-4Hyoscyamine Sulfate21 in 1 BOTTLETABLET213
71335-1647-5Hyoscyamine Sulfate60 in 1 BOTTLETABLET603
71335-1647-6Hyoscyamine Sulfate12 in 1 BOTTLETABLET123
71335-1647-7Hyoscyamine Sulfate90 in 1 BOTTLETABLET903
71335-1647-8Hyoscyamine Sulfate100 in 1 BOTTLETABLET1003
71335-1647-9Hyoscyamine Sulfate45 in 1 BOTTLETABLET453

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1647HYOSCYAMINE SULFATE TABLET [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 10 package rows20230413_57b26b7f-f22d-4ffb-a748-d430572f92a7.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 SulfateHYOSCYAMINE SULFATEBryant Ranch Prepack57b26b7f-f22d-4ffb-a748-d430572f92a72023-04-12Warnings, Adverse reactionsExact identifier
ndc (package): 71335-1647-7
ndc (product): 71335-1647
ndc11 (package): 71335164707

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletPSN57b26b7f-f22d-4ffb-a748-d430572f92a73
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletSCD57b26b7f-f22d-4ffb-a748-d430572f92a73
1046982hyoscyamine sulfate SL 0.125 Disintegrating Sublingual TabletSY57b26b7f-f22d-4ffb-a748-d430572f92a73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1647-77133516470790 TABLET in 1 BOTTLE (71335-1647-7) 90 tablet2022-03-100000-00-00NoNoCurrent