DICYCLOMINE HYDROCHLORIDE

Product NDC
61919-077
11-digit product format
619190077
Labeler code
61919
Product ID
61919-077_25c58c92-034c-0e8e-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICYCLOMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA085082
Marketing category
ANDA
Marketing start
2014-01-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-077-30DICYCLOMINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE303
61919-077-60DICYCLOMINE HYDROCHLORIDE60 in 1 BOTTLECAPSULE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-077-30EA - Each61919-0778a3165ee-d5bf-4839-bbeb-de48f9273b3712016-11-08
61919-077-60EA - Each61919-077284f12f0-7515-44cf-a1ec-83dfdd22ad9412015-04-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-077DICYCLOMINE HYDROCHLORIDE CAPSULE [DIRECT RX]3Legacy NDC, 2 package rows20161013_2131a563-f739-4aee-a3ea-cfdc399799ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN2131a563-f739-4aee-a3ea-cfdc399799ab3
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD2131a563-f739-4aee-a3ea-cfdc399799ab3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-077-306191900773030 in 1 BOTTLEHistorical
61919-077-606191900776060 in 1 BOTTLEHistorical