FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
68788-8751
11-digit product format
687888751
Labeler code
68788
Product ID
68788-8751_00f785fd-3c18-4e62-a0c2-18ce7ae30f25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA217916
Marketing category
ANDA
Marketing start
2023-09-13
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICYCLOMINE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991086

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f755a917-03bc-45af-a1e3-50286868bfdbProduct name920250303
f27796e1-d653-495b-932a-f51768e9be8aProduct name220211021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8751-2Dicyclomine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET204
68788-8751-3Dicyclomine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET304
68788-8751-6Dicyclomine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET604
68788-8751-9Dicyclomine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8751-2EA - Each68788-87516d4d113f-da51-4c59-9f48-314f54f66ccd12024-12-10
68788-8751-3EA - Each68788-87511c250fbd-0767-4217-8593-301cf91b784f12024-12-10
68788-8751-6EA - Each68788-875130f1d061-5123-41d1-a26b-3e03246ecfd112024-12-10
68788-8751-9EA - Each68788-8751e337e5ed-24fe-4806-ab28-b973067f6abf12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8751DICYCLOMINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 4 package rows20241222_3ee013cc-ab23-40a1-a44d-1d027c63b132.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN3ee013cc-ab23-40a1-a44d-1d027c63b1324
991086dicyclomine hydrochloride 20 MG Oral TabletSCD3ee013cc-ab23-40a1-a44d-1d027c63b1324

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8751-26878887510220 TABLET in 1 BOTTLE, PLASTIC (68788-8751-2) 20 tablet2023-09-13NoNoCurrent
68788-8751-36878887510330 TABLET in 1 BOTTLE, PLASTIC (68788-8751-3) 30 tablet2024-10-11NoNoCurrent
68788-8751-66878887510660 TABLET in 1 BOTTLE, PLASTIC (68788-8751-6) 60 tablet2024-10-11NoNoCurrent
68788-8751-96878887510990 TABLET in 1 BOTTLE, PLASTIC (68788-8751-9) 90 tablet2024-10-11NoNoCurrent