FDA.reportPublic FDA data

OSCIMIN

Product NDC
68047-252
11-digit product format
680470252
Labeler code
68047
Product ID
68047-252_41ac39ef-ea3c-2163-e063-6394a90aaf1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hyoscyamine Sulfate
Dosage form
TABLET
Route
ORAL
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
Rxcui1047905, 1149355

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68047-252-01OSCIMIN100 in 1 BOTTLETABLET10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68047-252-01EA - Each68047-252a8bf8c85-b3cf-4802-a7c0-9c302971511312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYOSCYAMINE SULFATEACTIVE INGREDIENTF2R8V82B84OSCIMIN (HYOSCYAMINE SULFATE) TABLET [LARKEN LABORATORIES, INC.]2
HYOSCYAMINEACTIVE MOIETYPX44XO846XOSCIMIN (HYOSCYAMINE SULFATE) TABLET [LARKEN LABORATORIES, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOSCIMIN (HYOSCYAMINE SULFATE) TABLET [LARKEN LABORATORIES, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOSCIMIN (HYOSCYAMINE SULFATE) TABLET [LARKEN LABORATORIES, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOSCIMIN (HYOSCYAMINE SULFATE) TABLET [LARKEN LABORATORIES, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OSCIMIN (HYOSCYAMINE SULFATE) TABLET [LARKEN LABORATORIES, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AOSCIMIN (HYOSCYAMINE SULFATE) TABLET [LARKEN LABORATORIES, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOSCIMIN (HYOSCYAMINE SULFATE) TABLET [LARKEN LABORATORIES, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOSCIMIN (HYOSCYAMINE SULFATE) TABLET [LARKEN LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68047-252OSCIMIN (HYOSCYAMINE SULFATE) TABLET [LARKEN LABORATORIES, INC.]11Current NDC, Legacy NDC, 1 package rows20241013_8504adad-f6d0-4671-b655-4b62bf29a516.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1047905hyoscyamine sulfate 0.125 MG Oral TabletPSN8504adad-f6d0-4671-b655-4b62bf29a51612
1149355OSCIMIN 0.125 MG Oral TabletPSN8504adad-f6d0-4671-b655-4b62bf29a51612
1149355hyoscyamine sulfate 0.125 MG Oral Tablet [Oscimin]SBD8504adad-f6d0-4671-b655-4b62bf29a51612
1047905hyoscyamine sulfate 0.125 MG Oral TabletSCD8504adad-f6d0-4671-b655-4b62bf29a51612
1149355Oscimin 0.125 MG Oral TabletSY8504adad-f6d0-4671-b655-4b62bf29a51612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68047-252-0168047025201100 TABLET in 1 BOTTLE (68047-252-01) 100 tablet2011-08-030000-00-00NoNoCurrent