Hyoscyamine Sulfate SL

Product NDC
42192-339
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 Identifiers#

Field, Values table
FieldValues
UniiF2R8V82B84
Rxcui1046982

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

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