FDA.reportPublic FDA data

Hyoscyamine Sulfate SL

Product NDC
42192-339
Requested package NDC
42192-339-01
11-digit product format
421920339
Labeler code
42192
Product ID
42192-339_40331302-66d2-ddb4-e063-6394a90a8bd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hyoscyamine sulfate
Dosage form
TABLET
Route
SUBLINGUAL
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 SL
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
8aab1dce-0699-4866-8707-33b4e2177bddAvailable 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
42192-339-01Hyoscyamine Sulfate SL100 in 1 BOTTLETABLET10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-339-01EA - Each42192-3392ed008c1-02f5-4bc7-a2f2-1fc06861a80712016-11-08
42192-339-05EA - Each42192-339312e7a05-45f0-4734-b4c4-6bc96b1ab52012016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-339HYOSCYAMINE SULFATE SL (HYOSCYAMINE SULFATE) TABLET [ACELLA PHARMACEUTICALS, LLC]12Current NDC, Legacy NDC, 1 package rows20241017_8aab1dce-0699-4866-8707-33b4e2177bdd.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 SULFATEAcella Pharmaceuticals, LLC8aab1dce-0699-4866-8707-33b4e2177bdd2025-10-02Warnings, Adverse reactionsExact identifier
ndc (package): 42192-339-01
ndc (product): 42192-339
ndc11 (package): 42192033901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletPSN8aab1dce-0699-4866-8707-33b4e2177bdd13
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletSCD8aab1dce-0699-4866-8707-33b4e2177bdd13
1046982hyoscyamine sulfate SL 0.125 Disintegrating Sublingual TabletSY8aab1dce-0699-4866-8707-33b4e2177bdd13
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
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletPSN4cc2a7a4-b549-b92a-e063-6294a90a51e31
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletSCD4cc2a7a4-b549-b92a-e063-6294a90a51e31
1046982hyoscyamine sulfate SL 0.125 Disintegrating Sublingual TabletSY4cc2a7a4-b549-b92a-e063-6294a90a51e31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-339-0142192033901100 TABLET in 1 BOTTLE (42192-339-01) 100 tablet2011-05-190000-00-00NoNoCurrent