FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
17856-0623
11-digit product format
178560623
Labeler code
17856
Product ID
17856-0623_a9259ed5-bdff-4291-8385-45ccb3e3a2b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA212286
Marketing category
ANDA
Marketing start
2020-05-22
Marketing end
0000-00-00
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/5mL
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0623-12024-04-17C16284748780-1d6a99b39-b15a-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION. DICYCLOMINE HYDROCHLORIDE oral solution Initial U.S. Approval: 1950
17856-0623-22024-04-17C16284748780-1d6a99b39-b15a-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION. DICYCLOMINE HYDROCHLORIDE oral solution Initial U.S. Approval: 1950
17856-0623-12024-01-30C16284748780-1d6a99b39-b15a-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION. DICYCLOMINE HYDROCHLORIDE oral solution Initial U.S. Approval: 1950
17856-0623-22024-01-30C16284748780-1d6a99b39-b15a-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION. DICYCLOMINE HYDROCHLORIDE oral solution Initial U.S. Approval: 1950
17856-0623-12022-03-04C16284748780-1d6a99b39-b15a-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION. DICYCLOMINE HYDROCHLORIDE oral solution Initial U.S. Approval: 1950
17856-0623-22022-03-04C16284748780-1d6a99b39-b15a-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION. DICYCLOMINE HYDROCHLORIDE oral solution Initial U.S. Approval: 1950
17856-0623-12022-01-28C16284748780-1d6a99b39-b15a-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION. DICYCLOMINE HYDROCHLORIDE oral solution Initial U.S. Approval: 1950
17856-0623-22022-01-28C16284748780-1d6a99b39-b15a-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION. DICYCLOMINE HYDROCHLORIDE oral solution Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0623-1Dicyclomine Hydrochloride72 in 1 PACKAGESOLUTION724
17856-0623-2Dicyclomine Hydrochloride72 in 1 BOX, UNIT-DOSESOLUTION724
17856-0623-3Dicyclomine Hydrochloride5 mL in 1 CUP, UNIT-DOSESOLUTION54
17856-0623-4Dicyclomine Hydrochloride10 mL in 1 CUP, UNIT-DOSESOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0623-1ML - Milliliter17856-0623191eff76-6b84-40f0-8023-ffa5cffa937612021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0623DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.]4Legacy NDC, 4 package rows20240418_7b466007-2be7-4f1d-a41b-f71c0c90b69e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991082dicyclomine HCl 10 MG in 5 mL Oral SolutionPSN7b466007-2be7-4f1d-a41b-f71c0c90b69e4
991082dicyclomine hydrochloride 2 MG/ML Oral SolutionSCD7b466007-2be7-4f1d-a41b-f71c0c90b69e4
991082dicyclomine HCl 10 MG per 5 ML Oral SolutionSY7b466007-2be7-4f1d-a41b-f71c0c90b69e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0623-11785606230172 CUP, UNIT-DOSE in 1 PACKAGE (17856-0623-1) > 5 mL in 1 CUP, UNIT-DOSE2020-06-300000-00-00NoNoCurrent
17856-0623-21785606230272 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0623-2) > 10 mL in 1 CUP, UNIT-DOSE2020-06-300000-00-00NoNoCurrent
17856-0623-3178560623035 mL in 1 CUP, UNIT-DOSE5 mlHistorical
17856-0623-41785606230410 mL in 1 CUP, UNIT-DOSE10 mlHistorical