FDA.reportPublic FDA data

Hyoscyamine Sulfate TAB

Product NDC
42708-183
11-digit product format
427080183
Labeler code
42708
Product ID
42708-183_46539e99-e8c6-7994-e063-6294a90a0a7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hyoscyamine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
QPharma, Inc.
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 TAB
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
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
fc7566e6-c043-fcd4-e053-6294a90a77e5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42708-183-56Hyoscyamine Sulfate TAB56 in 1 BOTTLE, PLASTICTABLET563

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-183HYOSCYAMINE SULFATE TAB (HYOSCYAMINE SULFATE) TABLET [QPHARMA INC]2Current NDC, 1 package rows20241123_fc7566e6-c043-fcd4-e053-6294a90a77e5.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 SULFATEQPharma, Inc.fc7566e6-c043-fcd4-e053-6294a90a77e52025-12-16Warnings, Adverse reactionsExact identifier
ndc (product): 42708-183

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1047905hyoscyamine sulfate 0.125 MG Oral TabletPSNfc7566e6-c043-fcd4-e053-6294a90a77e53
1047905hyoscyamine sulfate 0.125 MG Oral TabletSCDfc7566e6-c043-fcd4-e053-6294a90a77e53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42708-183-564270801835656 TABLET in 1 BOTTLE, PLASTIC (42708-183-56) 56 tablet2023-05-26YesNoCurrent