Dicyclomine Hydrochloride

Product NDC
55154-8183
11-digit product format
551548183
Labeler code
55154
Product ID
55154-8183_bc0e3cea-d404-45d4-afd6-57c05dc643e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA084285
Marketing category
ANDA
Marketing start
2018-10-04
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICYCLOMINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991061

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
55154-8183-0Dicyclomine Hydrochloride1 in 1 BLISTER PACKCAPSULE16
55154-8183-0Dicyclomine Hydrochloride10 in 1 BAGCAPSULE106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-8183DICYCLOMINE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH 107, LLC]4Current NDC, Legacy NDC, 2 package rows20240509_63b207da-159c-4cb5-8b06-616ed4811c12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSN63b207da-159c-4cb5-8b06-616ed4811c126
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCD63b207da-159c-4cb5-8b06-616ed4811c126

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-8183-05515481830010 BLISTER PACK in 1 BAG (55154-8183-0) / 1 CAPSULE in 1 BLISTER PACK10 blister pack2018-10-040000-00-00NoNoCurrent