Dicyclomine Hydrochloride

Product NDC
64725-0586
11-digit product format
647250586
Labeler code
64725
Product ID
64725-0586_67e197bb-1535-4f76-9672-ba62f836735b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA084285
Marketing category
ANDA
Marketing start
1974-09-30
Marketing end
0000-00-00
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
64725-0586-1Dicyclomine Hydrochloride100 in 1 BOTTLECAPSULE1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MDICYCLOMINE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XDICYCLOMINE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DICYCLOMINE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505DICYCLOMINE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYDICYCLOMINE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DICYCLOMINE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICYCLOMINE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DICYCLOMINE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
SHELLACINACTIVE INGREDIENT46N107B71ODICYCLOMINE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICYCLOMINE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0586DICYCLOMINE HYDROCHLORIDE CAPSULE [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140901_d64229cc-c087-4fcb-a31b-042cd6bd75d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSNd64229cc-c087-4fcb-a31b-042cd6bd75d02
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDd64229cc-c087-4fcb-a31b-042cd6bd75d02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0586-164725058601100 in 1 BOTTLEHistorical