Dicyclomine Hydrochloride

Product NDC
60760-665
11-digit product format
607600665
Labeler code
60760
Product ID
60760-665_1b2d5ed0-200b-97b1-e063-6394a90ab136
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA040317
Marketing category
ANDA
Marketing start
2023-04-25
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 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 HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCQ903KQA31
Rxcui991086

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
60760-665-30Dicyclomine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-665-30EA - Each60760-6652dee260f-823b-4e40-8e31-74a3ecf0666712024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-665DICYCLOMINE HYDROCHLORIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, 1 package rows20240619_1b2d5256-b75d-11f8-e063-6394a90ae9ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSN1b2d5256-b75d-11f8-e063-6394a90ae9ed1
991086dicyclomine hydrochloride 20 MG Oral TabletSCD1b2d5256-b75d-11f8-e063-6394a90ae9ed1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-665-306076006653030 TABLET in 1 BOTTLE, PLASTIC (60760-665-30) 30 tablet2024-06-12NoNoCurrent