Dicyclomine Hydrochloride

Product NDC
53808-0234
11-digit product format
538080234
Labeler code
53808
Product ID
53808-0234_6f87d871-e2de-4445-9ecf-d00bfeb0afec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICYCLOMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA085223
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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
53808-0234-12021-01-29C16284748780-1956f9ecf-bc0a-621f-e053-dbdaa90a74adDicyclomine HCl Capsules USP Dicyclomine HCl Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0234-1Dicyclomine Hydrochloride30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WODICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0234DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100611_f325dd3d-8ebe-4aa3-8c45-43438c75defe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSNf325dd3d-8ebe-4aa3-8c45-43438c75defe1
991086dicyclomine HCl 20 MG Oral TabletPSNf325dd3d-8ebe-4aa3-8c45-43438c75defe1
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDf325dd3d-8ebe-4aa3-8c45-43438c75defe1
991086dicyclomine hydrochloride 20 MG Oral TabletSCDf325dd3d-8ebe-4aa3-8c45-43438c75defe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0234-15380802340130 in 1 BLISTER PACKHistorical