Dicyclomine Hydrochloride

Product NDC
71610-209
11-digit product format
716100209
Labeler code
71610
Product ID
71610-209_dcd1f50a-a200-48b3-89f7-039081a9e72d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040230
Marketing category
ANDA
Marketing start
1999-02-26
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine Hydrochloride
Listing expiration
2026-12-31

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
71610-209-09Dicyclomine Hydrochloride9000 in 1 BOTTLETABLET90001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-209-09EA - Each71610-2091261568d-ca49-42ec-bcff-59999e6dcaf912019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-209DICYCLOMINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 1 package rows20181226_da2c43f8-1c3a-447f-8994-f9899fb5e141.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSNda2c43f8-1c3a-447f-8994-f9899fb5e1411
991086dicyclomine hydrochloride 20 MG Oral TabletSCDda2c43f8-1c3a-447f-8994-f9899fb5e1411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-209-09716100209099000 TABLET in 1 BOTTLE (71610-209-09) 9000 tablet2018-12-180000-00-00NoNoCurrent