FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
63187-784
11-digit product format
631870784
Labeler code
63187
Product ID
63187-784_2bab7712-de3d-45a1-a21c-b6273721bb28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA085223
Marketing category
ANDA
Marketing start
1986-07-30
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
63187-784-15Dicyclomine Hydrochloride15 in 1 BOTTLE, PLASTICTABLET154
63187-784-20Dicyclomine Hydrochloride20 in 1 BOTTLE, PLASTICTABLET204
63187-784-30Dicyclomine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET304
63187-784-60Dicyclomine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET604
63187-784-90Dicyclomine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-784DICYCLOMINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 5 package rows20220402_bd8b7fcd-04f4-4d1c-aa27-743aaf4c2876.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSNbd8b7fcd-04f4-4d1c-aa27-743aaf4c28764
991086dicyclomine hydrochloride 20 MG Oral TabletSCDbd8b7fcd-04f4-4d1c-aa27-743aaf4c28764

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-784-156318707841515 TABLET in 1 BOTTLE, PLASTIC (63187-784-15) 15 tablet2016-11-010000-00-00NoNoCurrent
63187-784-206318707842020 TABLET in 1 BOTTLE, PLASTIC (63187-784-20) 20 tablet2016-11-010000-00-00NoNoCurrent
63187-784-306318707843030 TABLET in 1 BOTTLE, PLASTIC (63187-784-30) 30 tablet2016-11-010000-00-00NoNoCurrent
63187-784-606318707846060 TABLET in 1 BOTTLE, PLASTIC (63187-784-60) 60 tablet2016-11-010000-00-00NoNoCurrent
63187-784-906318707849090 TABLET in 1 BOTTLE, PLASTIC (63187-784-90) 90 tablet2016-11-010000-00-00NoNoCurrent