Dicyclomine

Product NDC
53808-0899
11-digit product format
538080899
Labeler code
53808
Product ID
53808-0899_da42f97f-21e6-4847-9b8d-9975b6be3ccc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA040161
Marketing category
ANDA
Marketing start
2014-01-01
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
2019-12-31
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
53808-0899-2Dicyclomine60 in 1 BLISTER PACKTABLET603

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FD&C RED NO. 4INACTIVE INGREDIENTX3W0AM1JLXDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0899DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3Legacy NDC, 1 package rows20141024_88942e82-b798-4122-9ea2-0932ef09357f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN88942e82-b798-4122-9ea2-0932ef09357f3
991086dicyclomine HCl 20 MG Oral TabletPSN88942e82-b798-4122-9ea2-0932ef09357f3
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD88942e82-b798-4122-9ea2-0932ef09357f3
991086dicyclomine hydrochloride 20 MG Oral TabletSCD88942e82-b798-4122-9ea2-0932ef09357f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0899-25380808990260 in 1 BLISTER PACKHistorical