FDA.reportPublic FDA data

Hyoscyamine Sulfate TAB

Product NDC
70518-3847
Requested package NDC
70518-3847-1
11-digit product format
705183847
Labeler code
70518
Product ID
70518-3847_3f8bc3b1-e61e-9f63-e063-6294a90a021a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hyoscyamine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-08-31
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 TAB
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
1047905Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c1c89510-6381-466f-be1a-6b104a335b56Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3847-0Hyoscyamine Sulfate TAB90 in 1 BOTTLE, PLASTICTABLET907
70518-3847-1Hyoscyamine Sulfate TAB180 in 1 BOTTLE, PLASTICTABLET1807

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3847HYOSCYAMINE SULFATE TAB (HYOSCYAMINE SULFATE) TABLET [REMEDYREPACK INC.]6Current NDC, 2 package rows20241206_c1c89510-6381-466f-be1a-6b104a335b56.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 TABHYOSCYAMINE SULFATEREMEDYREPACK INC.c1c89510-6381-466f-be1a-6b104a335b562026-06-09Warnings, Adverse reactionsExact identifier
ndc (package): 70518-3847-1
ndc (product): 70518-3847
ndc11 (package): 70518384701

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1047905hyoscyamine sulfate 0.125 MG Oral TabletPSNc1c89510-6381-466f-be1a-6b104a335b567
1047905hyoscyamine sulfate 0.125 MG Oral TabletSCDc1c89510-6381-466f-be1a-6b104a335b567

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3847-170518384701180 TABLET in 1 BOTTLE, PLASTIC (70518-3847-1) 180 tablet2024-06-27NoNoCurrent