FDA.reportPublic FDA data

Hyoscyamine Sulfate ODT

Product NDC
42192-338
Requested package NDC
42192-338-01
11-digit product format
421920338
Labeler code
42192
Product ID
42192-338_41adc6a7-c16a-066d-e063-6394a90affc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hyoscyamine sulfate
Dosage form
TABLET, ORALLY DISINTEGRATING
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 ODT
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
1046985Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eef6babc-241f-40b6-b8c8-daa92bbd0a25Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42192-338-01Hyoscyamine Sulfate ODT100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-338-01EA - Each42192-338b0163585-6f05-4172-b1c5-26e4d65902b212016-11-08
42192-338-05EA - Each42192-3384f666bb4-2b7d-46ea-8a08-64870d33ea5212016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-338HYOSCYAMINE SULFATE ODT (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [ACELLA PHARMACEUTICALS, LLC]13Current NDC, Legacy NDC, 1 package rows20241017_eef6babc-241f-40b6-b8c8-daa92bbd0a25.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 ODTHYOSCYAMINE SULFATEAcella Pharmaceuticals, LLCeef6babc-241f-40b6-b8c8-daa92bbd0a252025-10-21Warnings, Adverse reactionsExact identifier
ndc (package): 42192-338-01
ndc (product): 42192-338
ndc11 (package): 42192033801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046985hyoscyamine sulfate 0.125 MG Disintegrating Oral TabletPSNeef6babc-241f-40b6-b8c8-daa92bbd0a2515
1046985hyoscyamine sulfate 0.125 MG Disintegrating Oral TabletSCDeef6babc-241f-40b6-b8c8-daa92bbd0a2515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42192-338-0142192033801100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (42192-338-01) 2011-05-190000-00-00NoNoCurrent