Dicyclomine Hydrochloride

Product NDC
67296-0126
11-digit product format
672960126
Labeler code
67296
Product ID
67296-0126_d5fbea2f-f34d-900f-e053-2995a90a3887
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA085223
Marketing category
ANDA
Marketing start
2012-01-01
Marketing end
0000-00-00
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0126-0Dicyclomine Hydrochloride28 in 1 BOTTLETABLET287
67296-0126-1Dicyclomine Hydrochloride10 in 1 BOTTLETABLET107
67296-0126-5Dicyclomine Hydrochloride56 in 1 BOTTLETABLET567
67296-0126-7Dicyclomine Hydrochloride15 in 1 BOTTLETABLET157

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0126DICYCLOMINE HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]7Legacy NDC, 4 package rows20240608_41d74ebf-7775-0f7f-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN41d74ebf-7775-0f7f-e054-00144ff8d46c7
991086dicyclomine hydrochloride 20 MG Oral TabletSCD41d74ebf-7775-0f7f-e054-00144ff8d46c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-0126-06729601260028 TABLET in 1 BOTTLE (67296-0126-0) 28 tablet2012-01-010000-00-00NoNoCurrent
67296-0126-16729601260110 TABLET in 1 BOTTLE (67296-0126-1) 10 tablet2012-01-010000-00-00NoNoCurrent
67296-0126-56729601260556 TABLET in 1 BOTTLE (67296-0126-5) 56 tablet2012-01-010000-00-00NoNoCurrent
67296-0126-76729601260715 in 1 BOTTLEHistorical