Dicyclomine Hydrochloride

Product NDC
62135-718
11-digit product format
621350718
Labeler code
62135
Product ID
62135-718_241f85bb-925f-a594-e063-6394a90a92fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA084285
Marketing category
ANDA
Marketing start
1974-09-30
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dicyclomine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICYCLOMINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991061, 991086

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
62135-718-90Dicyclomine Hydrochloride90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-718-90EA - Each62135-7183447da3d-1b82-433f-91c8-ad352b9ca51112023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-718DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [CHARTWELL RX, LLC]5Current NDC, 1 package rows20241012_d628ac1c-404d-45eb-8aab-0e550c95ed4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991061dicyclomine HCl 10 MG Oral CapsulePSNd628ac1c-404d-45eb-8aab-0e550c95ed4a5
991086dicyclomine HCl 20 MG Oral TabletPSNd628ac1c-404d-45eb-8aab-0e550c95ed4a5
991061dicyclomine hydrochloride 10 MG Oral CapsuleSCDd628ac1c-404d-45eb-8aab-0e550c95ed4a5
991086dicyclomine hydrochloride 20 MG Oral TabletSCDd628ac1c-404d-45eb-8aab-0e550c95ed4a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-718-906213507189090 CAPSULE in 1 BOTTLE (62135-718-90) 90 capsule2023-07-26NoNoHistorical