FDA.reportPublic FDA data

OSCIMIN

Product NDC
68047-253
11-digit product format
680470253
Labeler code
68047
Product ID
68047-253_41495987-d924-1713-e063-6294a90a9235
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
SUBLINGUAL
Labeler
Larken Laboratories, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-08-03
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
OSCIMIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYOSCYAMINE SULFATE.125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF2R8V82B84
Rxcui1046982, 1652363

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
68047-253-01OSCIMIN100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68047-253-01EA - Each68047-2538aa56575-1685-42d5-98c3-7e7857ee8d0a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYOSCYAMINE SULFATEACTIVE INGREDIENTF2R8V82B84OSCIMIN (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [LARKEN LABORATORIES, INC.]3
HYOSCYAMINEACTIVE MOIETYPX44XO846XOSCIMIN (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [LARKEN LABORATORIES, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOSCIMIN (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [LARKEN LABORATORIES, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOSCIMIN (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [LARKEN LABORATORIES, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOSCIMIN (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [LARKEN LABORATORIES, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OSCIMIN (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [LARKEN LABORATORIES, INC.]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AOSCIMIN (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [LARKEN LABORATORIES, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOSCIMIN (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [LARKEN LABORATORIES, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOSCIMIN (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [LARKEN LABORATORIES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68047-253OSCIMIN (HYOSCYAMINE SULFATE) TABLET, ORALLY DISINTEGRATING [LARKEN LABORATORIES, INC.]11Current NDC, Legacy NDC, 1 package rows20241013_2d5fa637-0696-40fe-9bc1-fcb6f07a50f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletPSN2d5fa637-0696-40fe-9bc1-fcb6f07a50f612
1652363OSCIMIN 0.125 MG Sublingual TabletPSN2d5fa637-0696-40fe-9bc1-fcb6f07a50f612
1652363hyoscyamine sulfate 0.125 MG Sublingual Tablet [Oscimin]SBD2d5fa637-0696-40fe-9bc1-fcb6f07a50f612
1046982hyoscyamine sulfate 0.125 MG Sublingual TabletSCD2d5fa637-0696-40fe-9bc1-fcb6f07a50f612
1046982hyoscyamine sulfate SL 0.125 Disintegrating Sublingual TabletSY2d5fa637-0696-40fe-9bc1-fcb6f07a50f612
1652363Oscimin 0.125 MG Sublingual TabletSY2d5fa637-0696-40fe-9bc1-fcb6f07a50f612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68047-253-0168047025301100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68047-253-01) 2011-08-030000-00-00NoNoCurrent