FDA.reportPublic FDA data

SENNA-PLUS

Product NDC
68788-8780
11-digit product format
687888780
Labeler code
68788
Product ID
68788-8780_f3461f8b-5297-4bb1-8b22-f8426f2f5eeb
Type
HUMAN OTC DRUG
Nonproprietary name
Sennosides and Docusate Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-11
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
50; 8.6 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SENNA-PLUS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM50 mg/1
SENNOSIDES8.6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0, 3FYP5M0IJX
Rxcui998740

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8780-1SENNA-PLUS100 in 1 BOTTLETABLET1002
68788-8780-3SENNA-PLUS30 in 1 BOTTLETABLET302
68788-8780-8SENNA-PLUS120 in 1 BOTTLETABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8780-1EA - Each68788-878088d4df5e-593f-4a20-8e38-8d2afdf6cd9712025-01-14
68788-8780-3EA - Each68788-8780e332dd0f-363b-490e-bfb7-b30ddfe7851a12025-01-14
68788-8780-8EA - Each68788-87805283dd0e-d33f-47bd-a48b-0ef2105c4edd12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8780SENNA-PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 3 package rows20241213_d7146449-c43e-460a-9ae0-aa1966eaa3b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSNd7146449-c43e-460a-9ae0-aa1966eaa3b62
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCDd7146449-c43e-460a-9ae0-aa1966eaa3b62
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSYd7146449-c43e-460a-9ae0-aa1966eaa3b62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8780-168788878001100 TABLET in 1 BOTTLE (68788-8780-1) 100 tablet2024-12-11NoNoHistorical
68788-8780-36878887800330 TABLET in 1 BOTTLE (68788-8780-3) 30 tablet2024-12-11NoNoHistorical
68788-8780-868788878008120 TABLET in 1 BOTTLE (68788-8780-8) 120 tablet2024-12-11NoNoHistorical