FDA.reportPublic FDA data

Dicyclomine Hydrochloride

Product NDC
66336-911
11-digit product format
663360911
Labeler code
66336
Product ID
66336-911_43b8794f-1137-4f23-be99-f2c7c3a63444
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA085082
Marketing category
ANDA
Marketing start
1986-06-19
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66336-911-062019-11-27C16284748780-19855e2a2-4689-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride. Dicyclomine hydrochloride capsules, for oral use Dicyclomine hydrochloride tablets, for oral use Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-911-06Dicyclomine Hydrochloride6 in 1 BOTTLE, PLASTICCAPSULE62

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-911DICYCLOMINE HYDROCHLORIDE CAPSULE [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 1 package rows20131105_baae1478-e5e8-44d1-bb8a-9f456861491f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSNbaae1478-e5e8-44d1-bb8a-9f456861491f2
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDbaae1478-e5e8-44d1-bb8a-9f456861491f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-911-06663360911066 in 1 BOTTLE, PLASTICHistorical