FDA.reportPublic FDA data

Hyoscyamine Sulfate TAB

Product NDC
42192-340
11-digit product format
421920340
Labeler code
42192
Product ID
42192-340_40334131-5c80-1b60-e063-6394a90ae21f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hyoscyamine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Acella Pharmaceuticals, LLC
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
49fe1783-ab0c-4adb-869b-384121cf7f05Available 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
42192-340-01Hyoscyamine Sulfate TAB100 in 1 BOTTLETABLET10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-340-01EA - Each42192-340d0a746eb-3b28-4299-a53e-9d7c06c2428e12016-11-08
42192-340-05EA - Each42192-340434c9e6f-0292-4c87-8d15-44bd8e7d5a9212016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-340HYOSCYAMINE SULFATE TAB (HYOSCYAMINE SULFATE) TABLET [ACELLA PHARMACEUTICALS, LLC]12Current NDC, Legacy NDC, 1 package rows20241017_49fe1783-ab0c-4adb-869b-384121cf7f05.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 SULFATEAcella Pharmaceuticals, LLC49fe1783-ab0c-4adb-869b-384121cf7f052025-10-02Warnings, Adverse reactionsExact identifier
ndc (product): 42192-340

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1047905hyoscyamine sulfate 0.125 MG Oral TabletPSN49fe1783-ab0c-4adb-869b-384121cf7f0513
1047905hyoscyamine sulfate 0.125 MG Oral TabletSCD49fe1783-ab0c-4adb-869b-384121cf7f0513
1047905hyoscyamine sulfate 0.125 MG Oral TabletPSNc1c89510-6381-466f-be1a-6b104a335b567
1047905hyoscyamine sulfate 0.125 MG Oral TabletSCDc1c89510-6381-466f-be1a-6b104a335b567
1047905hyoscyamine sulfate 0.125 MG Oral TabletPSNf75765ce-262c-e832-e053-6394a90a60663
1047905hyoscyamine sulfate 0.125 MG Oral TabletPSNfc7566e6-c043-fcd4-e053-6294a90a77e53
1047905hyoscyamine sulfate 0.125 MG Oral TabletSCDf75765ce-262c-e832-e053-6394a90a60663
1047905hyoscyamine sulfate 0.125 MG Oral TabletSCDfc7566e6-c043-fcd4-e053-6294a90a77e53
1047905hyoscyamine sulfate 0.125 MG Oral TabletPSNb8759036-81f9-4e31-8763-9e42cf78d9c51
1047905hyoscyamine sulfate 0.125 MG Oral TabletSCDb8759036-81f9-4e31-8763-9e42cf78d9c51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-340-0142192034001100 TABLET in 1 BOTTLE (42192-340-01) 100 tablet2011-05-190000-00-00NoNoCurrent