Dicyclomine Hydrochloride

Product NDC
51655-940
11-digit product format
516550940
Labeler code
51655
Product ID
51655-940_497459e7-6d89-87d4-e063-6394a90a052d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicyclomine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA040230
Marketing category
ANDA
Marketing start
2021-07-15
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
20 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 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
51655-940-26Dicyclomine Hydrochloride90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-940DICYCLOMINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]1Current NDC, 1 package rows20230404_da82cb46-7b4b-1ef5-e053-2a95a90ad10d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991086dicyclomine HCl 20 MG Oral TabletPSNda82cb46-7b4b-1ef5-e053-2a95a90ad10d2
991086dicyclomine hydrochloride 20 MG Oral TabletSCDda82cb46-7b4b-1ef5-e053-2a95a90ad10d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-940-265165509402690 TABLET in 1 BOTTLE, PLASTIC (51655-940-26) 90 tablet2021-07-15NoNoCurrent